CN101361979B - Solid preparation film coating agent and preparation method thereof - Google Patents
Solid preparation film coating agent and preparation method thereof Download PDFInfo
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- CN101361979B CN101361979B CN2008101514789A CN200810151478A CN101361979B CN 101361979 B CN101361979 B CN 101361979B CN 2008101514789 A CN2008101514789 A CN 2008101514789A CN 200810151478 A CN200810151478 A CN 200810151478A CN 101361979 B CN101361979 B CN 101361979B
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- 238000002360 preparation method Methods 0.000 title claims abstract description 24
- 239000007888 film coating Substances 0.000 title claims abstract description 23
- 238000009501 film coating Methods 0.000 title claims abstract description 23
- 239000003795 chemical substances by application Substances 0.000 title claims abstract description 22
- 239000007787 solid Substances 0.000 title claims abstract description 16
- 239000004372 Polyvinyl alcohol Substances 0.000 claims abstract description 50
- 229920002451 polyvinyl alcohol Polymers 0.000 claims abstract description 50
- 239000011347 resin Substances 0.000 claims abstract description 50
- 229920005989 resin Polymers 0.000 claims abstract description 50
- 239000003086 colorant Substances 0.000 claims abstract description 21
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 12
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 12
- 239000000463 material Substances 0.000 claims description 41
- 238000000576 coating method Methods 0.000 claims description 37
- 239000011248 coating agent Substances 0.000 claims description 36
- -1 hydroxypropyl Chemical group 0.000 claims description 36
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 20
- 239000004408 titanium dioxide Substances 0.000 claims description 10
- 229940093429 polyethylene glycol 6000 Drugs 0.000 claims 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 description 6
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 5
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 claims description 5
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 4
- 238000005303 weighing Methods 0.000 claims description 4
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims description 3
- 239000004353 Polyethylene glycol 8000 Substances 0.000 claims description 3
- 238000006136 alcoholysis reaction Methods 0.000 claims description 3
- 229940085678 polyethylene glycol 8000 Drugs 0.000 claims description 3
- 235000019446 polyethylene glycol 8000 Nutrition 0.000 claims description 3
- 238000002156 mixing Methods 0.000 claims description 2
- 238000006116 polymerization reaction Methods 0.000 claims description 2
- 238000010008 shearing Methods 0.000 claims description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract description 36
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract description 36
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 5
- 230000035699 permeability Effects 0.000 abstract description 4
- 239000000126 substance Substances 0.000 abstract description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 1
- 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 abstract 1
- 239000010408 film Substances 0.000 description 34
- 230000000149 penetrating effect Effects 0.000 description 19
- 239000010409 thin film Substances 0.000 description 18
- 239000000470 constituent Substances 0.000 description 11
- 239000003814 drug Substances 0.000 description 10
- 230000000694 effects Effects 0.000 description 8
- 239000002131 composite material Substances 0.000 description 6
- 238000010521 absorption reaction Methods 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 230000008859 change Effects 0.000 description 3
- 230000002950 deficient Effects 0.000 description 3
- 235000013305 food Nutrition 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 239000003960 organic solvent Substances 0.000 description 3
- 239000004014 plasticizer Substances 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 230000004888 barrier function Effects 0.000 description 2
- 238000005266 casting Methods 0.000 description 2
- 230000000857 drug effect Effects 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000005507 spraying Methods 0.000 description 2
- 239000004925 Acrylic resin Substances 0.000 description 1
- 229920000178 Acrylic resin Polymers 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 230000003044 adaptive effect Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 239000012736 aqueous medium Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 229940126678 chinese medicines Drugs 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 239000003433 contraceptive agent Substances 0.000 description 1
- 230000002254 contraceptive effect Effects 0.000 description 1
- 230000002596 correlated effect Effects 0.000 description 1
- 230000000875 corresponding effect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000003912 environmental pollution Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 210000004276 hyalin Anatomy 0.000 description 1
- 229940040145 liniment Drugs 0.000 description 1
- 239000000865 liniment Substances 0.000 description 1
- 238000005461 lubrication Methods 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 210000000214 mouth Anatomy 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920002689 polyvinyl acetate Polymers 0.000 description 1
- 239000011118 polyvinyl acetate Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 239000002195 soluble material Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 230000008719 thickening Effects 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 229920003169 water-soluble polymer Polymers 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention relates to a solid preparation film coating agent which mainly contains hydroxypropyl methyl cellulose and polyvinyl alcohol resins, and can also contain polyethylene glycol and a colorant according to demands. The film coating agent can effectively reduce the permeability of water vapor and improve the tolerance capacity of coated substances to the environment.
Description
Technical field
The present invention relates to a kind of film coating agent, particularly a kind of film coating agent that is used for solid preparation.
Background technology
Film coating agent normally is made up of film former, plasticizer, coloring agent etc.; mode by spraying is coated on dosage surface; form certain thickness thin film; the coating that can be used for solid pharmaceutical preparation, food processing, confection and crop seeds plays and improves mouthfeel, moisture protection, raising product stability and bright-coloured pleasing effect.Since the sixties in 20th century, it is the filmogen preparation that film coating procedure mainly adopts hydroxypropyl emthylcellulose.Hydroxypropyl emthylcellulose dissolves in the organic solvent system of aqueous medium and general film coating agent, and applied widely, easy to operate, and the coating process is relatively easy, is main filmogen.Hydroxypropyl emthylcellulose is a water-soluble material, and solvent compatibility is good, can use 10-15% aqueous solution or organic solvent spraying.Because hydroxypropyl emthylcellulose is easy and simple to handle, stable performance becomes the primary raw material that coating materials uses.
But in the use of specialities such as Chinese medicine, some situations that can not meet the demands have but been produced.For example for the strong extractum coating tablets of moisture absorption, can not effectively completely cut off moisture and enter, cause medicine moisture absorption ratio height, composition changes, and influences drug effect; The thin film pliability is poor, and the tablet edge produces disruptive probability height; The solution viscosity height, the operating time is long.Add other and have the filmogen of superperformance in prescription, composite use can improve the deficiency of hydroxypropyl emthylcellulose performance, improves the adaptive capacity of coating materials to Chinese medicine.
And after the single macromolecule filming material film forming,, inevitably there is defective in others though have advantage in one aspect.Have the materials with different properties composite membrane-forming if adopt two kinds, the advantage of two kinds of materials can be brought into play simultaneously, the defective of its existence is simultaneously remedied, and obtains the prescription with superior performance.
Once more because the excellent compatibility of hydroxypropyl emthylcellulose, can with the common film forming of multiple macromolecular material.Adding insoluble polymer such as acrylic resin can reduce the thin film poisture-penetrability in hydroxypropyl emthylcellulose, but also can influence the disintegrate and the stripping of medicine simultaneously.Particularly, particularly evident to the influence of disintegrate for extractum class Chinese medicine, may prolong 15-30 minutes, cause disintegrating medicinal defective.Simultaneously, when operation, with an organic solvent, can cause cost to rise and environmental pollution.So the high-performance prescription of seeking in the water soluble is highly significant.
Polyvinyl alcohol resin is to be got through alkali catalyzed alcoholysis by polyvinyl acetate, is the high molecular weight water soluble polymer that extensive use is arranged in pharmaceuticals industry.Have very strong water solublity, easy film forming, and the mechanical performance of its film is good; Toxicity is very low, nonirritant.Approveds such as Japan, the U.S. and China are as the adjuvant of medicine and food industry.Based on polyvinyl alcohol resin good film property and adhesiveness, can be used for as contraceptive membrane, oral cavity with the liniment of film and transdermal patch etc.; In ophthalmic preparation, play thickening and lubrication; In tablet, can be used as adhesive; Colorcon company is that independent filmogen prepares film coating agent with polyvinyl alcohol resin, is applied to the drug coating field.
The coating materials for preparing separately with hydroxypropyl emthylcellulose has tensile strength preferably, but the film forming pliability of institute is poor, and the clothing film easily produces problems such as distortion, sign bridge formation; And moistureproof indifferent, for the strong extractum sheet of moisture absorption, can not effectively completely cut off moisture and enter, cause medicine moisture absorption ratio height, composition changes, and influences drug effect.The ductility of polyvinyl alcohol resin and pliability are very strong, the effect of well isolated moisture is arranged simultaneously, but tensile strength are low, and be poor to the protection of label.
And in patent and scientific and technical literature, do not find that hydroxypropyl emthylcellulose and polyvinyl alcohol resin The combined should be used for forming the solid preparation film coating agent.
Summary of the invention
The object of the present invention is to provide a kind of solid preparation film coating agent.This coating materials can improve by the environment tolerance of coating substance.
Coating materials provided by the invention contains hydroxypropyl emthylcellulose, polyvinyl alcohol resin.
Coating materials provided by the invention also contains Polyethylene Glycol.
Coating materials provided by the invention can also contain coloring agent as required.
The degree of polymerization of the polyvinyl alcohol resin in the coating materials provided by the invention is 500-2400, and alcoholysis degree is 85%-89%.And employed polyvinyl alcohol resin powder fineness is preferably 50-100 μ m.
Polyethylene Glycol of the present invention is one or more in PEG400, Macrogol 4000, polyethylene glycol 6000 or the Polyethylene Glycol 8000.
Coloring agent of the present invention is one or more in titanium dioxide, Pulvis Talci, color lake or the ferrum oxide.And employed coloring agent fineness is preferably between 0.1-20 μ m.
The invention provides a kind of solid preparation film coating agent, the quality that wherein said hydroxypropyl emthylcellulose accounts for coating materials is 5-65%, is preferably 25-50%; The quality that described polyvinyl alcohol resin accounts for coating materials is 7-60%, is preferably 15-45%; The quality that described Polyethylene Glycol accounts for coating materials is 5-25%, is preferably 8-16%; The quality of described colorant comprises coating materials is 0.1-55%, is preferably 20-45%.
Preparation method according to solid preparation film coating agent of the present invention may further comprise the steps:
1) takes by weighing materials such as hydroxypropyl emthylcellulose, polyvinyl alcohol resin, Polyethylene Glycol, coloring agent in proportion;
2) described material is added in the high-speed shearing machine, make mixing of materials even with 350-600 rev/mins speed;
3) the high speed shear motor speed is brought up to 900-1200 rev/mins, coloring agent is fully disperseed, obtain the coating materials powder body of color even.
In the present invention, polyvinyl alcohol resin is added in the film coating agent, plays the effect of film former jointly with hydroxypropyl emthylcellulose.
In the present invention, polyvinyl alcohol resin and hydroxypropyl emthylcellulose are formed the composite membrane-forming material, the preparation coating materials.Behind the compound preparation coating materials of polyvinyl alcohol resin and hydroxypropyl emthylcellulose, combine the advantage of two kinds of materials, remedied its shortcoming, formed thin film with good mechanical properties and humidity resistance.Coating materials of the present invention not only can be used for most of Chinese medicines and Western medicine oral formulations, also can be used for the film-coated various fields of needs such as food, obtaining by the good coating effect of coating component, and lower moisture absorption ratio.
After the detailed description of the specific embodiment below having read, various purposes of the present invention and advantage will become very clear for the person of ordinary skill in the field.
The specific embodiment
The following examples are used to further specify the present invention rather than are used for limiting the present invention.
Usually measure by the thin film that uses casting the to form method permeability of cheers for the evaluation of thin film water vapour permeability is known.Its method is: be that solvent is mixed with solution with coating materials with water, in smooth substrate,, closely be covered in the weighing bottleneck of splendid attire dry silica gel, put into climatic chamber by casting, the uniform thin film of dry preparation thickness, the penetrating rate of aqueous vapor is calculated in regularly accurately weighing.
The evaluation of film properties adopts known film stretching experiment to measure: same thin films, be cut into dumbbell shape, and use the anti-experiment instrument of opening, data such as the tensile strength of working sample, strain, elastic modelling quantity:
Tensile strength: the suffered maximum stress of unit are during the thin film fracture.Illustrate that thin film resists the ability of external force.
Strain: the thin film ratio that length increases before fracture.Strain increase illustrative material pliability and ductility are good.
Elastic modelling quantity: the ratio of stress and strain is film hardness and inflexible index.
Embodiment 1
Prescription 1
Each constituent mass ratio of filling a prescription is: hydroxypropyl emthylcellulose 5%, polyvinyl alcohol resin are 60%, and polyethylene glycol 6000 is 5%, titanium dioxide 18%, color lake 12%.
As follows with the penetrating rate data of the correlated aqueous vapor of film coating agent prescription of independent use hydroxypropyl emthylcellulose:
| Prescription 1 | The HPMC prescription | |
| The penetrating rate of aqueous vapor (μ g/cm 2/h) | 1.42 | 3.11 |
After adding polyvinyl alcohol resin in the hydroxypropyl emthylcellulose, the penetrating rate of the aqueous vapor of clothing film descends, illustrate that the thin film humidity resistance is significantly improved, this is because the interpolation of polyvinyl alcohol resin causes the increase of hydroxypropyl emthylcellulose degree of crystallinity and the change of membrane structure.The hydroxypropyl emthylcellulose prescription that the interpolation polyvinyl alcohol resin is described is compared with the hydroxypropyl emthylcellulose prescription that does not add polyvinyl alcohol resin, has strengthened the aqueous vapor barrier of thin film.
Simultaneously, use the prescription 1 of polyvinyl alcohol resin relatively to see the following form with using HPMC prescription film properties data:
| Prescription 1 | The HPMC prescription | |
| Tensile strength N/cm 2 | 12.3 | 18.6 |
| Strain % | 4.4 | 1.5 |
| Elastic modelling quantity | 1.7 | 7.9 |
The HPMC thin film has higher tensile strength, can effectively increase label intensity behind the coating, and the impact of opposing external force avoid the breakage of tablet and clothing film, but the pliability of film is lower.Polyvinyl alcohol resin has very strong ductility and intensity is lower slightly, forms composite with HPMC, and the performance of two kinds of materials is able to replenish mutually, improve the toughness of prescription, and intensity can not reduce obviously, uses the coating effect that can obtain in coating.The degree of flexibility of clothing film and the content of polyvinyl alcohol resin have direct relation, and content is high more, and pliability is good more.
Embodiment 2
Prescription 2
Each constituent mass ratio of filling a prescription is: hydroxypropyl emthylcellulose 65%, polyvinyl alcohol resin are 7%, and PEG400 is 10%, Pulvis Talci 11%, titanium dioxide 5%, ferrum oxide 2%.
The penetrating rate data of its aqueous vapor are as follows:
| Prescription 2 | The HPMC prescription | |
| The penetrating rate of aqueous vapor (μ g/cm 2/h) | 2.18 | 3.11 |
Simultaneously, use the prescription 2 of polyvinyl alcohol resin and the film properties data of using the HPMC prescription relatively to see the following form:
| Prescription 2 | The HPMC prescription | |
| Tensile strength N/cm 2 | 15.3 | 18.6 |
| Strain % | 2.1 | 1.5 |
| Elastic modelling quantity | 4.4 | 7.9 |
The prescription that hydroxypropyl emthylcellulose content is high, the prescription pliability higher than polyvinyl alcohol resin content descends to some extent, but tensile strength is good, and the protection label is better resisted external impacts.
Embodiment 3
Prescription 3
Prescription is after preferably, and each constituent mass ratio is: hydroxypropyl emthylcellulose 25%, polyvinyl alcohol resin are 45%, and polyethylene glycol 6000 is 5%, titanium dioxide 15%, color lake 10%.
The penetrating rate data of its aqueous vapor are as follows:
| Prescription 3 | The HPMC prescription | |
| The penetrating rate of aqueous vapor (μ g/cm 2/h) | 1.63 | 3.11 |
Simultaneously, use the prescription 3 of polyvinyl alcohol resin relatively to see the following form with using HPMC prescription film properties data:
| Prescription 3 | The HPMC prescription | |
| Tensile strength N/cm 2 | 12.9 | 18.6 |
| Strain % | 3.6 | 1.5 |
| Elastic modelling quantity | 3.8 | 7.9 |
Embodiment 4
Prescription 4
Prescription 4 each constituent mass ratio are: hydroxypropyl emthylcellulose 50%, polyvinyl alcohol resin are 15%, and Macrogol 4000 is 8%, titanium dioxide 12%, color lake 4%, Pulvis Talci 11%.
The penetrating rate data of its aqueous vapor are as follows:
| Prescription 4 | The HPMC prescription | |
| The penetrating rate of aqueous vapor (μ g/cm 2/h) | 2.04 | 3.11 |
Simultaneously, use the prescription 4 of polyvinyl alcohol resin relatively to see the following form with using HPMC prescription film properties data:
| Prescription 4 | The HPMC prescription | |
| Tensile strength N/cm 2 | 14.1 | 18.6 |
| Strain % | 2.4 | 1.5 |
| Elastic modelling quantity | 4.2 | 7.9 |
Embodiment 5
Prescription 5
Prescription 5 each constituent mass ratio are: hydroxypropyl emthylcellulose 35%, polyvinyl alcohol resin are 35%, and Polyethylene Glycol 8000 is 6%, titanium dioxide 16%, color lake 8%.
| Prescription 5 | The HPMC prescription | |
| The penetrating rate of aqueous vapor (μ g/cm 2/h) | 1.86 | 3.11 |
Simultaneously, use the prescription 5 of polyvinyl alcohol resin relatively to see the following form with using HPMC prescription film properties data:
| Prescription 5 | The HPMC prescription | |
| Tensile strength N/cm 2 | 14.2 | 18.6 |
| Strain % | 2.8 | 1.5 |
| Elastic modelling quantity | 3.1 | 7.9 |
Embodiment 6
Prescription 6
For reaching better plasticization effect, can improve the content of plasticizer Polyethylene Glycol, and use the Polyethylene Glycol of different model composite.Prescription 6 each constituent mass ratio are: hydroxypropyl emthylcellulose 35%, polyvinyl alcohol resin are 20%, and Macrogol 4000 is 8%, and polyethylene glycol 6000 is 17%, titanium dioxide 15%, color lake 5%.
| Prescription 6 | The HPMC prescription | |
| The penetrating rate of aqueous vapor (μ g/cm 2/h) | 1.93 | 3.11 |
Simultaneously, use the prescription 6 of polyvinyl alcohol resin relatively to see the following form with using HPMC prescription film properties data:
| Prescription 5 | The HPMC prescription | |
| Tensile strength N/cm 2 | 13.3 | 18.6 |
| Strain % | 3.0 | 1.5 |
| Elastic modelling quantity | 3.1 | 7.9 |
Embodiment 7
In prescription, do not use coloring agent, when only using hydroxypropyl emthylcellulose and polyvinyl alcohol resin, can form clear films, embody the original appearance characteristics of product, play protection simultaneously and reduce the aqueous vapor permeation.
Prescription 7
Prescription 7 each constituent mass ratio are: hydroxypropyl emthylcellulose 40%, polyvinyl alcohol resin are 60%.
| Prescription 7 | The HPMC prescription | |
| The penetrating rate of aqueous vapor (μ g/cm 2/h) | 0.93 | 3.11 |
Simultaneously, use the prescription 7 of polyvinyl alcohol resin relatively to see the following form with using HPMC prescription film properties data:
| Prescription 7 | The HPMC prescription | |
| Tensile strength N/cm 2 | 7.41 | 18.6 |
| Strain % | 37 | 1.5 |
| Elastic modelling quantity | 0.14 | 7.9 |
Only use filmogen in the prescription, intensity is low, and clothing film pliability and ductility improve; Reduced the slit that coloring agent forms simultaneously, made thin film more fine and close, the penetrating rate of aqueous vapor reduces.
Embodiment 8
Prescription 8
Prescription 8 each constituent mass ratio are: hydroxypropyl emthylcellulose 35%, polyvinyl alcohol resin are 45%, and PEG400 is 7%, and polyethylene glycol 6000 is 13%.
| Prescription 8 | The HPMC prescription | |
| The penetrating rate of aqueous vapor (μ g/cm 2/h) | 1.03 | 3.11 |
Simultaneously, use the prescription 8 of polyvinyl alcohol resin relatively to see the following form with using HPMC prescription film properties data:
| Prescription 8 | The HPMC prescription | |
| Tensile strength N/cm 2 | 10.32 | 18.6 |
| Strain % | 2.1 | 1.5 |
| Elastic modelling quantity | 0.84 | 7.9 |
Transparent prescription adds the plasticizer Polyethylene Glycol, has kept the transparency of thin film, and the penetrating rate of thin film mechanical performance and aqueous vapor is not affected, and solution viscosity reduces, and operating characteristics improves.
Embodiment 9
Add coloring agent in the prescription as required and can play covering, effect such as attractive in appearance and bright-colored.The coloring agent minimum amount is 0.1%, and along with colorant content increases, covering power and bright-colored degree improve, and the filmogen ratio descends, and corresponding film properties and moisture barrier properties descend, but still are better than common hydroxypropyl emthylcellulose prescription.
Prescription 9
Prescription 9 each constituent mass ratio are: hydroxypropyl emthylcellulose 25%, polyvinyl alcohol resin are 20%, titanium dioxide 30%, Pulvis Talci 25%.
| Prescription 9 | The HPMC prescription | |
| The penetrating rate of aqueous vapor (μ g/cm 2/h) | 2.71 | 3.11 |
Simultaneously, use the prescription 9 of polyvinyl alcohol resin relatively to see the following form with using HPMC prescription film properties data:
| Prescription 9 | The HPMC prescription | |
| Tensile strength N/cm 2 | 18.04 | 18.6 |
| Strain % | 1.6 | 1.5 |
| Elastic modelling quantity | 6.24 | 7.9 |
Embodiment 10
Prescription 10
Prescription 10 each constituent mass ratio are: hydroxypropyl emthylcellulose 35%, polyvinyl alcohol resin are 15%, and Macrogol 4000 is 5%, titanium dioxide 21%, Pulvis Talci 25%, color lake 9%.
| Prescription 10 | The HPMC prescription | |
| The penetrating rate of aqueous vapor (μ g/cm 2/h) | 2.63 | 3.11 |
Simultaneously, use the prescription 10 of polyvinyl alcohol resin relatively to see the following form with using HPMC prescription film properties data:
| Prescription 10 | The HPMC prescription | |
| Tensile strength N/cm 2 | 17.42 | 18.6 |
| Strain % | 1.8 | 1.5 |
| Elastic modelling quantity | 5.47 | 7.9 |
Embodiment 11
Prescription 11
Prescription 11 each constituent mass ratio are: hydroxypropyl emthylcellulose 35%, polyvinyl alcohol resin are 45%, and PEG400 is 7%, and polyethylene glycol 6000 is 12.9%, and the color lake is 0.1%.
| Prescription 11 | The HPMC prescription | |
| The penetrating rate of aqueous vapor (μ g/cm 2/h) | 1.09 | 3.11 |
Simultaneously, use the prescription 11 of polyvinyl alcohol resin relatively to see the following form with using HPMC prescription film properties data:
| Prescription 11 | The HPMC prescription | |
| Tensile strength N/cm 2 | 10.84 | 18.6 |
| Strain % | 2.1 | 1.5 |
| Elastic modelling quantity | 0.93 | 7.9 |
When the coloring agent consumption more after a little while, the performance of film and permeability compare with hyaline membrane change little.
From above-mentioned example as seen, composite coating materials performance obviously improves, and has played the former homogenous material effect that is beyond one's reach, and the thin film humidity resistance is significantly improved, and the tensile strength of clothing film and degree of flexibility can change as required, have very high using value.
As requested, the specific embodiment of the invention is here disclosed in detail.Yet, should be appreciated that disclosed specific embodiment only is the example of invention, and invention can be implemented with multiple and optional form.Although specific embodiment is illustrated and describes, should not think that the specific embodiment of these explanations and description is all possible invention form.And be interpreted as, the speech that uses in description is descriptive vocabulary rather than words of limitation, and should be appreciated that, do not depart from the scope of the present invention with spirit under can make multiple variation.
Claims (7)
1. a solid preparation film coating agent is characterized in that, it is made up of hydroxypropyl emthylcellulose, polyvinyl alcohol resin, Polyethylene Glycol, coloring agent, and wherein, the quality of described hydroxypropyl emthylcellulose accounts for the 5-65% of coating materials gross mass; The quality of described polyvinyl alcohol resin accounts for the 7-60% of coating materials gross mass; The quality of described Polyethylene Glycol accounts for the 5-25% of coating materials gross mass; The quality of described coloring agent accounts for the 0.1-55% of coating materials gross mass, and the degree of polymerization of described polyvinyl alcohol resin is 500-2400, and alcoholysis degree is 85%-89%.
2. solid preparation film coating agent according to claim 1 is characterized in that the quality of described hydroxypropyl emthylcellulose accounts for the 25-50% of coating materials gross mass; The quality of described polyvinyl alcohol resin accounts for the 15-45% of coating materials gross mass; The quality of described Polyethylene Glycol accounts for the 8-16% of coating materials gross mass; The quality of described coloring agent accounts for the 20-45% of coating materials gross mass.
3. according to each described solid preparation film coating agent in claim 1 or 2, it is characterized in that the polyvinyl alcohol resin powder fineness is 50-100 μ m.
4. according to each described solid preparation film coating agent in claim 1 or 2, it is characterized in that poly-ethanol is one or more in PEG400, Macrogol 4000, polyethylene glycol 6000 or the Polyethylene Glycol 8000.
5. according to each described solid preparation film coating agent in claim 1 or 2, it is characterized in that coloring agent is one or more in titanium dioxide, Pulvis Talci, color lake or the ferrum oxide.
6. according to each described solid preparation film coating agent in claim 1 or 2, the particle diameter that it is characterized in that coloring agent is between 0.1-20 μ m.
7. the preparation method of each described solid preparation film coating agent in the claim 1～6 is characterized in that may further comprise the steps:
1) takes by weighing hydroxypropyl emthylcellulose, polyvinyl alcohol resin, Polyethylene Glycol, coloring agent in proportion;
2) above-mentioned material is added in the high-speed shearing machine, make mixing of materials even with 350-600 rev/min speed;
3) the high speed shear motor speed is brought up to 900-1200 rev/min, coloring agent is fully disperseed, obtain the coating materials powder body of color even.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101514789A CN101361979B (en) | 2008-09-19 | 2008-09-19 | Solid preparation film coating agent and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101514789A CN101361979B (en) | 2008-09-19 | 2008-09-19 | Solid preparation film coating agent and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101361979A CN101361979A (en) | 2009-02-11 |
| CN101361979B true CN101361979B (en) | 2011-01-19 |
Family
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| CN2008101514789A Active CN101361979B (en) | 2008-09-19 | 2008-09-19 | Solid preparation film coating agent and preparation method thereof |
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| CN101829334B (en) * | 2010-03-30 | 2012-07-18 | 天津博科林药品包装技术有限公司 | Film coating agent for extract medicament solid preparation and preparation method thereof |
| CN104548113B (en) * | 2014-12-11 | 2017-12-01 | 天津博科林药品包装技术有限公司 | A kind of production technology of film coating agent |
| CN110638778A (en) * | 2019-08-28 | 2020-01-03 | 株洲千金药业股份有限公司 | Tablet water-soluble coating and preparation method and application thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1328449A (en) * | 1998-09-30 | 2001-12-26 | Basf公司 | Application of water-soluble or water-dispersible polymerizates which contain poly-ether and which are used as coating agent, binding agent and/or as film-forming auxiliary agent in pharmaceutical for |
| EP1552819A2 (en) * | 2004-01-08 | 2005-07-13 | Societe D'exploitation De Produits Pour Les Industries Chimiques, S.E.P.P.I.C. | Porous film forming granules, process for their preparation and application for coating tablets and sweets |
| WO2007110878A1 (en) * | 2006-03-27 | 2007-10-04 | Panacea Biotec Ltd | Sustained release pharmaceutical composition on the basis of a release system comprising an acid-soluble polymer and a ph-dependent polymer. |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1328449A (en) * | 1998-09-30 | 2001-12-26 | Basf公司 | Application of water-soluble or water-dispersible polymerizates which contain poly-ether and which are used as coating agent, binding agent and/or as film-forming auxiliary agent in pharmaceutical for |
| EP1552819A2 (en) * | 2004-01-08 | 2005-07-13 | Societe D'exploitation De Produits Pour Les Industries Chimiques, S.E.P.P.I.C. | Porous film forming granules, process for their preparation and application for coating tablets and sweets |
| WO2007110878A1 (en) * | 2006-03-27 | 2007-10-04 | Panacea Biotec Ltd | Sustained release pharmaceutical composition on the basis of a release system comprising an acid-soluble polymer and a ph-dependent polymer. |
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| CN101361979A (en) | 2009-02-11 |
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