CN114522146A - White titanium-free film coating material and preparation method and application thereof - Google Patents
White titanium-free film coating material and preparation method and application thereof Download PDFInfo
- Publication number
- CN114522146A CN114522146A CN202210074385.0A CN202210074385A CN114522146A CN 114522146 A CN114522146 A CN 114522146A CN 202210074385 A CN202210074385 A CN 202210074385A CN 114522146 A CN114522146 A CN 114522146A
- Authority
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- China
- Prior art keywords
- coating material
- film coating
- free film
- white titanium
- food
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000463 material Substances 0.000 title claims abstract description 43
- 238000009501 film coating Methods 0.000 title claims abstract description 35
- 239000007888 film coating Substances 0.000 title claims abstract description 35
- 238000002360 preparation method Methods 0.000 title claims abstract description 24
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims abstract description 28
- 229910000019 calcium carbonate Inorganic materials 0.000 claims abstract description 14
- 238000002156 mixing Methods 0.000 claims abstract description 14
- 239000002994 raw material Substances 0.000 claims abstract description 13
- 235000013305 food Nutrition 0.000 claims abstract description 11
- 239000007787 solid Substances 0.000 claims abstract description 10
- 239000005913 Maltodextrin Substances 0.000 claims abstract description 7
- 229920002774 Maltodextrin Polymers 0.000 claims abstract description 7
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 7
- 239000004372 Polyvinyl alcohol Substances 0.000 claims abstract description 7
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims abstract description 7
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract description 7
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract description 7
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract description 7
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims abstract description 7
- 229940035034 maltodextrin Drugs 0.000 claims abstract description 7
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 7
- 229920002451 polyvinyl alcohol Polymers 0.000 claims abstract description 7
- 239000000203 mixture Substances 0.000 claims description 3
- 238000007873 sieving Methods 0.000 claims description 3
- 238000000034 method Methods 0.000 claims description 2
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 abstract description 34
- 239000004408 titanium dioxide Substances 0.000 abstract description 17
- 239000011248 coating agent Substances 0.000 abstract description 8
- 238000000576 coating method Methods 0.000 abstract description 8
- 239000003814 drug Substances 0.000 abstract description 7
- 231100000357 carcinogen Toxicity 0.000 abstract description 6
- 239000003183 carcinogenic agent Substances 0.000 abstract description 6
- 230000000694 effects Effects 0.000 abstract description 6
- 239000012467 final product Substances 0.000 abstract description 4
- 230000036541 health Effects 0.000 abstract description 4
- 230000033228 biological regulation Effects 0.000 description 3
- 239000000049 pigment Substances 0.000 description 3
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 230000002411 adverse Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 235000019658 bitter taste Nutrition 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000009505 enteric coating Methods 0.000 description 1
- 239000002702 enteric coating Substances 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 239000011343 solid material Substances 0.000 description 1
- 239000008247 solid mixture Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 238000009492 tablet coating Methods 0.000 description 1
- 239000002700 tablet coating Substances 0.000 description 1
Classifications
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
-
- 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
- A23L29/035—Organic compounds containing oxygen as heteroatom
-
- 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
- A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Nutrition Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention provides a white titanium-free film coating material, a preparation method and a preparation application thereof, wherein the white titanium-free film coating material comprises the following raw materials in percentage by weight: 32-38% of food-grade calcium carbonate, 17-23% of hydroxypropyl methyl cellulose, 12-18% of maltodextrin, 12-18% of talcum powder, 7-13% of polyvinyl alcohol and 2-8% of polyethylene glycol, and the white titanium-free film coating material is applied to the medicine or food solid preparation. The white titanium-free film coating material is prepared by mixing food-grade calcium carbonate, hydroxypropyl methyl cellulose, maltodextrin, talcum powder, polyvinyl alcohol, polyethylene glycol and other raw materials, replaces a coating material containing two kinds of carcinogens such as titanium dioxide and the like, meets various standards, and ensures the life health of people; by adjusting the weight percentage of each raw material, namely adopting food-grade calcium carbonate with the weight percentage of 35%, the final product has the same effect of good coverage rate as that brought by titanium dioxide, and simultaneously has good film forming property and stability.
Description
[ technical field ] A
The invention relates to a film coating material, in particular to a white titanium-free film coating material, a preparation method of the white titanium-free film coating material and preparation application of the white titanium-free film coating material.
[ background of the invention ]
In the production of solid preparations of medicines and foods, in order to make them more stable, effective, convenient, mask bitter taste and unpleasant odor, and achieve the purpose of slow release, enteric coating, etc., it is necessary to coat the surfaces with suitable materials, and this process is called coating. The coated material is referred to as coating material.
The film coating has the advantages of no obvious increase of tablet weight, simple and convenient operation, no influence on disintegration time and the like, and also has good protection and stabilization effects, so the film coating is widely used in dosage forms such as tablets, pills, granules, capsules and the like.
The film coating material is usually composed of high molecular material, plasticizer, solid material, pigment and solvent, wherein the pigment is added mainly for shading light and satisfying the aesthetic effect of the product.
In the prior art, titanium dioxide (titanium dioxide) is often used as a pigment of a white coating material because of its good coverage. However, the European Union issued Committee authorized REGULATIONs (EU)2020/217 (COMMISSION DELEGATED REGULATION (EU)2020/217of 4October2019) at 18.2.2020, listed titanium dioxide as a class of carcinogens and required "packaging of solid mixtures containing 1% or more titanium dioxide required a corresponding labeling".
This regulation was carried out on 09/2021, which limits the use of titanium dioxide in the pharmaceutical and food fields, and most european pharmaceutical and food importers now require that the titanium dioxide be excluded from the tablet coating provided by the supplier.
[ summary of the invention ]
Aiming at the problems pointed out in the background technology, the invention provides a white titanium-free film coating material, a preparation method of the white titanium-free film coating material and preparation application of the white titanium-free film coating material.
A white titanium-free film coating material comprises the following raw materials in percentage by weight:
the preparation method of the white titanium-free film coating material comprises the following steps:
mixing and crushing: mixing and crushing food-grade calcium carbonate, hydroxypropyl methyl cellulose and maltodextrin at the temperature of 15-35 ℃;
sieving and mixing: and (3) adding the talcum powder, the polyvinyl alcohol and the polyethylene glycol which pass through a 100-mesh screen into the mixture in the step (i) for fully mixing.
Further, the white titanium-free film coating material prepared according to the above preparation method is used for the application of a pharmaceutical or food solid preparation.
In conclusion, the beneficial effects of the invention are as follows:
1. the white titanium-free film coating material is prepared by mixing food-grade calcium carbonate, hydroxypropyl methyl cellulose, maltodextrin, talcum powder, polyvinyl alcohol, polyethylene glycol and other raw materials, replaces a coating material containing two kinds of carcinogens such as titanium dioxide and the like, meets various standards, and ensures the life health of people;
2. by adjusting the weight percentage of each raw material, namely adopting 35 percent of food-grade calcium carbonate, the final product has the same good covering rate effect as that brought by titanium dioxide, and simultaneously has good film forming property and stability;
3. the white titanium-free film coating material with the food-grade calcium carbonate is applied to the medicine or food solid preparation, the application range of the white titanium-free film coating material is enlarged, and the market competitiveness of the white titanium-free film coating material is greatly improved.
[ detailed description ] embodiments
First, the design of the present invention is described as follows: the coating material in the prior art contains titanium dioxide, and the titanium dioxide is classified into two carcinogens, which cause adverse effects on the life health of people, and the like.
A white titanium-free film coating material comprises the following raw materials in percentage by weight:
the white titanium-free film coating material prepared from the raw materials in percentage by weight greatly reduces two carcinogens such as titanium dioxide content by replacing titanium dioxide with food-grade calcium carbonate, and in order to realize good coverage rate brought by carbon dioxide, the embodiment adjusts the weight percentage of the raw materials, namely, adopts 35% of food-grade calcium carbonate in percentage by weight, and the final product has good coverage rate which is the same as that of titanium dioxide, and simultaneously has good film forming property and stability.
The preparation method of the white titanium-free film coating material comprises the following steps:
mixing and crushing: mixing and crushing food-grade calcium carbonate, hydroxypropyl methyl cellulose and maltodextrin at the temperature of 15-35 ℃;
sieving and mixing: at the temperature of 15-35 ℃, the talcum powder, the polyvinyl alcohol and the polyethylene glycol which pass through the 100-mesh screen are added into the mixture in the step (i) and fully mixed.
In the preparation process, the temperature of crushing, mixing, screening and remixing, the particle size of the raw materials and the tightness need to be strictly controlled.
The white titanium-free film coating material prepared according to the preparation method can be applied to medicines or food solid preparations. The medicine or food solid preparation is edible, and after the white titanium-free film coating material is coated and applied to the medicine or food solid preparation, an accelerated test needs to be carried out to test various indexes of the coated solid preparation, and when the indexes are qualified, the coating material meets the requirements.
In conclusion, the white titanium-free film coating material is prepared by mixing food-grade calcium carbonate, hydroxypropyl methylcellulose, maltodextrin, talcum powder, polyvinyl alcohol, polyethylene glycol and other raw materials, replaces the coating material containing two kinds of carcinogens such as titanium dioxide and the like, meets various standards, and ensures the life health of people; by adjusting the weight percentage of each raw material, namely adopting 35 percent of food-grade calcium carbonate, the final product has the same good covering rate effect as that brought by titanium dioxide, and simultaneously has good film forming property and stability; the white titanium-free film coating material with the food-grade calcium carbonate is applied to the medicine or food solid preparation, the application range of the white titanium-free film coating material is enlarged, and the market competitiveness of the white titanium-free film coating material is greatly improved.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (3)
1. A white titanium-free film coating material is characterized by comprising the following raw materials in percentage by weight:
2. a method for preparing the white titanium-free film coating material of claim 1, comprising the steps of:
mixing and crushing: mixing and crushing food-grade calcium carbonate, hydroxypropyl methyl cellulose and maltodextrin at the temperature of 15-35 ℃;
sieving and mixing: at the temperature of 15-35 ℃, the talcum powder, the polyvinyl alcohol and the polyethylene glycol which pass through the 100-mesh screen are added into the mixture in the step (i) and fully mixed.
3. Use of the white titanium-free film coating material prepared by the preparation method according to claim 2 for a pharmaceutical or food solid preparation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210074385.0A CN114522146A (en) | 2022-01-21 | 2022-01-21 | White titanium-free film coating material and preparation method and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210074385.0A CN114522146A (en) | 2022-01-21 | 2022-01-21 | White titanium-free film coating material and preparation method and application thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN114522146A true CN114522146A (en) | 2022-05-24 |
Family
ID=81620116
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210074385.0A Pending CN114522146A (en) | 2022-01-21 | 2022-01-21 | White titanium-free film coating material and preparation method and application thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN114522146A (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006123765A1 (en) * | 2005-05-20 | 2006-11-23 | Daiichi Sankyo Company, Limited | Film coated preparation |
| CN102295788A (en) * | 2011-06-21 | 2011-12-28 | 上海拜瑞曼克生物科技有限公司 | Film coating formula containing calcium carbonate, usage method thereof and purpose thereof |
| CN104984348A (en) * | 2015-07-20 | 2015-10-21 | 上海浦力膜制剂辅料有限公司 | Film coating premixing agent and preparing method thereof |
| CN106492222A (en) * | 2016-10-31 | 2017-03-15 | 上海新菲尔生物科技有限公司 | A kind of aqueouss strengthen moisture-proofing film coating premix and preparation method |
-
2022
- 2022-01-21 CN CN202210074385.0A patent/CN114522146A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006123765A1 (en) * | 2005-05-20 | 2006-11-23 | Daiichi Sankyo Company, Limited | Film coated preparation |
| CN102295788A (en) * | 2011-06-21 | 2011-12-28 | 上海拜瑞曼克生物科技有限公司 | Film coating formula containing calcium carbonate, usage method thereof and purpose thereof |
| CN104984348A (en) * | 2015-07-20 | 2015-10-21 | 上海浦力膜制剂辅料有限公司 | Film coating premixing agent and preparing method thereof |
| CN106492222A (en) * | 2016-10-31 | 2017-03-15 | 上海新菲尔生物科技有限公司 | A kind of aqueouss strengthen moisture-proofing film coating premix and preparation method |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
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Application publication date: 20220524 |