CN104958272B - A kind of stomach dissolved film coating pre-mix dose and preparation method thereof - Google Patents
A kind of stomach dissolved film coating pre-mix dose and preparation method thereof Download PDFInfo
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- CN104958272B CN104958272B CN201510467977.9A CN201510467977A CN104958272B CN 104958272 B CN104958272 B CN 104958272B CN 201510467977 A CN201510467977 A CN 201510467977A CN 104958272 B CN104958272 B CN 104958272B
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- 239000007888 film coating Substances 0.000 title claims abstract description 29
- 238000009501 film coating Methods 0.000 title claims abstract description 29
- UHZZMRAGKVHANO-UHFFFAOYSA-M chlormequat chloride Chemical compound [Cl-].C[N+](C)(C)CCCl UHZZMRAGKVHANO-UHFFFAOYSA-M 0.000 title claims abstract description 23
- 210000002784 stomach Anatomy 0.000 title claims abstract description 20
- 238000002360 preparation method Methods 0.000 title abstract description 9
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 51
- 238000002156 mixing Methods 0.000 claims abstract description 31
- 235000019640 taste Nutrition 0.000 claims abstract description 17
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 12
- 229920000881 Modified starch Polymers 0.000 claims abstract description 12
- 239000004014 plasticizer Substances 0.000 claims abstract description 12
- 238000004040 coloring Methods 0.000 claims abstract description 10
- 239000003605 opacifier Substances 0.000 claims abstract description 10
- 239000011363 dried mixture Substances 0.000 claims abstract description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 7
- 239000008213 purified water Substances 0.000 claims abstract description 5
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical group O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 30
- 239000000463 material Substances 0.000 claims description 24
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 18
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 18
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 18
- 229960003943 hypromellose Drugs 0.000 claims description 18
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 17
- 238000000034 method Methods 0.000 claims description 17
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 17
- 239000004408 titanium dioxide Substances 0.000 claims description 15
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical group OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 14
- 150000004676 glycans Chemical class 0.000 claims description 14
- 229920001282 polysaccharide Polymers 0.000 claims description 14
- 239000005017 polysaccharide Substances 0.000 claims description 14
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical group O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 claims description 12
- 229940013618 stevioside Drugs 0.000 claims description 12
- OHHNJQXIOPOJSC-UHFFFAOYSA-N stevioside Natural products CC1(CCCC2(C)C3(C)CCC4(CC3(CCC12C)CC4=C)OC5OC(CO)C(O)C(O)C5OC6OC(CO)C(O)C(O)C6O)C(=O)OC7OC(CO)C(O)C(O)C7O OHHNJQXIOPOJSC-UHFFFAOYSA-N 0.000 claims description 12
- 235000019202 steviosides Nutrition 0.000 claims description 12
- 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 9
- 229960003511 macrogol Drugs 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 9
- 239000007788 liquid Substances 0.000 claims description 5
- 235000005979 Citrus limon Nutrition 0.000 claims description 4
- 235000021355 Stearic acid Nutrition 0.000 claims description 4
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 4
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 4
- 239000008117 stearic acid Substances 0.000 claims description 4
- 244000131522 Citrus pyriformis Species 0.000 claims description 3
- 239000012528 membrane Substances 0.000 claims description 2
- 238000012546 transfer Methods 0.000 claims description 2
- 244000248349 Citrus limon Species 0.000 claims 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 235000014113 dietary fatty acids Nutrition 0.000 claims 1
- 239000000194 fatty acid Substances 0.000 claims 1
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- 150000004665 fatty acids Chemical class 0.000 claims 1
- 229910052749 magnesium Inorganic materials 0.000 claims 1
- 239000011777 magnesium Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 abstract description 23
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- 238000000227 grinding Methods 0.000 abstract description 5
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- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 24
- 238000001514 detection method Methods 0.000 description 24
- 238000012797 qualification Methods 0.000 description 20
- 238000012360 testing method Methods 0.000 description 19
- 238000002474 experimental method Methods 0.000 description 18
- 239000007937 lozenge Substances 0.000 description 11
- 239000001525 mentha piperita l. herb oil Substances 0.000 description 10
- 150000001875 compounds Chemical class 0.000 description 9
- 235000019477 peppermint oil Nutrition 0.000 description 9
- 238000005070 sampling Methods 0.000 description 8
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 description 8
- 230000004075 alteration Effects 0.000 description 6
- 229940046011 buccal tablet Drugs 0.000 description 6
- 239000006189 buccal tablet Substances 0.000 description 6
- 238000007689 inspection Methods 0.000 description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 6
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 5
- 238000005516 engineering process Methods 0.000 description 5
- 239000000523 sample Substances 0.000 description 5
- 239000002904 solvent Substances 0.000 description 5
- 239000002202 Polyethylene glycol Substances 0.000 description 4
- 235000012730 carminic acid Nutrition 0.000 description 4
- 238000002845 discoloration Methods 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 229920001223 polyethylene glycol Polymers 0.000 description 4
- 239000000341 volatile oil Substances 0.000 description 4
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 3
- 229920002472 Starch Polymers 0.000 description 3
- 238000005562 fading Methods 0.000 description 3
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- 235000019698 starch Nutrition 0.000 description 3
- -1 this problem Substances 0.000 description 3
- PNEYBMLMFCGWSK-UHFFFAOYSA-N Alumina Chemical compound [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 2
- SGHZXLIDFTYFHQ-UHFFFAOYSA-L Brilliant Blue Chemical compound [Na+].[Na+].C=1C=C(C(=C2C=CC(C=C2)=[N+](CC)CC=2C=C(C=CC=2)S([O-])(=O)=O)C=2C(=CC=CC=2)S([O-])(=O)=O)C=CC=1N(CC)CC1=CC=CC(S([O-])(=O)=O)=C1 SGHZXLIDFTYFHQ-UHFFFAOYSA-L 0.000 description 2
- 239000001856 Ethyl cellulose Substances 0.000 description 2
- 244000246386 Mentha pulegium Species 0.000 description 2
- 235000016257 Mentha pulegium Nutrition 0.000 description 2
- 235000004357 Mentha x piperita Nutrition 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
- 230000000996 additive effect Effects 0.000 description 2
- 239000010692 aromatic oil Substances 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 230000005574 cross-species transmission Effects 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
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- 235000019325 ethyl cellulose Nutrition 0.000 description 2
- 235000001050 hortel pimenta Nutrition 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000003921 oil Substances 0.000 description 2
- 235000019198 oils Nutrition 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 229940069328 povidone Drugs 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 description 2
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 description 1
- 241000205585 Aquilegia canadensis Species 0.000 description 1
- 244000241235 Citrullus lanatus Species 0.000 description 1
- 235000012828 Citrullus lanatus var citroides Nutrition 0.000 description 1
- 241000207199 Citrus Species 0.000 description 1
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 description 1
- IMROMDMJAWUWLK-UHFFFAOYSA-N Ethenol Chemical compound OC=C IMROMDMJAWUWLK-UHFFFAOYSA-N 0.000 description 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 1
- OFOBLEOULBTSOW-UHFFFAOYSA-N Malonic acid Chemical compound OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 description 1
- 240000002853 Nelumbo nucifera Species 0.000 description 1
- 235000006508 Nelumbo nucifera Nutrition 0.000 description 1
- 235000006510 Nelumbo pentapetala Nutrition 0.000 description 1
- 241000233855 Orchidaceae Species 0.000 description 1
- 229920003081 Povidone K 30 Polymers 0.000 description 1
- 241000219784 Sophora Species 0.000 description 1
- 244000228451 Stevia rebaudiana Species 0.000 description 1
- 235000021307 Triticum Nutrition 0.000 description 1
- 244000098338 Triticum aestivum Species 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 238000006136 alcoholysis reaction Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
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- 235000020971 citrus fruits Nutrition 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 238000007334 copolymerization reaction Methods 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
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- 229940079593 drug Drugs 0.000 description 1
- 229960004667 ethyl cellulose Drugs 0.000 description 1
- 238000013100 final test Methods 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 150000002576 ketones Chemical class 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 229940041616 menthol Drugs 0.000 description 1
- OJURWUUOVGOHJZ-UHFFFAOYSA-N methyl 2-[(2-acetyloxyphenyl)methyl-[2-[(2-acetyloxyphenyl)methyl-(2-methoxy-2-oxoethyl)amino]ethyl]amino]acetate Chemical compound C=1C=CC=C(OC(C)=O)C=1CN(CC(=O)OC)CCN(CC(=O)OC)CC1=CC=CC=C1OC(C)=O OJURWUUOVGOHJZ-UHFFFAOYSA-N 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 229940068918 polyethylene glycol 400 Drugs 0.000 description 1
- 229940068984 polyvinyl alcohol Drugs 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- HELXLJCILKEWJH-NCGAPWICSA-N rebaudioside A Chemical compound O([C@H]1[C@H](O)[C@@H](CO)O[C@H]([C@@H]1O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O HELXLJCILKEWJH-NCGAPWICSA-N 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of stomach dissolved film coating pre-mix dose, which includes the component of following parts by weight：30 50 parts of filmogen, 5 10 parts of antiplastering aid, 5 15 parts of opacifier, 5 20 parts of plasticizer, 5 20 parts of pregelatinized starch, 0.5 5 parts of taste agent, 0.5 5 parts of colouring agent.Its preparation method：(1) filmogens of above-mentioned parts by weight, antiplastering aid, plasticizer, pregelatinized starch, taste agent are taken, uniformly 1h, 35 45 DEG C of dry 5h are mixed with 10 15 parts of purified water or ethanol；(2) colouring agent, the opacifier of above-mentioned parts by weight are added in the dried mixture of upper step, after mixing 0.5 1h, grinder grinding 5h is transferred to, crosses 50 mesh sieves, you can obtain pre-mixing agent.There is obvious metachromatism by ten days substantially without obvious metachromatism by two days under original high humidity normal temperature condition in the coating that the film coating pre-mix dose of the present invention makes.The preparation method of the present invention is simple, it is highly practical, facilitate controllable, the pre-mixing agent particle and powder of suitable particle size can be directly acquired.
Description
Technical field
The invention belongs to drug coating to make formula and technology field, and in particular to a kind of stomach dissolution type film coating is pre-
Mixture and preparation method thereof.
Background technology
The film-coated technique in China is promoted and applied and started late, in the 1980s, some large-scale pharmacy corporations of China
Just start to introduce this technology, in recent years, with film-coated technique China's preparation production in developing rapidly, some with
Promote and apply the technology and grow development as emerging rapidly in large numbersBamboo shoots after a spring rain to the professional technique company for developing the related coating material of operation,
Positive impetus is played for extensive use of the film-coated technique in preparation industry.
Buccal tablet on the market adds taste and bright-colored beautiful mostly at present.But due to lozenge plain piece component itself
Complexity and diversity, film-coated technique are difficult the spilling metachromatism for solving the fragrant oils of peppermint oil etc. in plain piece.This hair
The bright spilling discoloration for solving the fragrant oils such as this problem, peppermint oil well is mainly caused by the following aspects.(1) it is thin
A series of problems, such as lotus oil additive amount is excessive, causes clothing film covering in coating process irregular, adhesive force degradation；(2) film
The addition of taste agent is excessive in pre-mixing agent, causes the film forming of clothing film to reduce, and influences the stability of clothing film, causes peppermint oil spill
Go out；(3) packaging technique is there are problem, the dissolvent solid content of coating solution and weightening, piece bed tempertaure during coating, discharge rate etc.；(4)
The problems such as selection of the raw materials such as toner, film forming agent and adaptability.
The content of the invention
In order to solve the problems, such as that above-mentioned film coating cannot entirely prevent the spilling color-change technology of peppermint oils aromatic oil, this hair
It is bright to provide a kind of film coating pre-mix dose for the buccal tablet requirement for meeting the aromatic oil of oils containing peppermint, while also disclose that this is thin
The preparation method of film coating pre-mixing agent.
The present invention provides a kind of stomach dissolved film coating pre-mix dose, which includes the component of following parts by weight：Into
30-50 parts of membrane material, 5-10 parts of antiplastering aid, 5-15 parts of opacifier, 5-20 parts of plasticizer, 5-20 parts of pregelatinized starch, taste agent
0.5-5 parts, 0.5-5 parts of colouring agent.
Filmogen includes the component of following parts by weight：1-5 parts of hypromellose, 1-3 parts of polyvinyl alcohol, copolymerization dimension
1-2 parts of ketone, 1-2 parts of pulullan polysaccharide.
Antiplastering aid is selected from talcum powder, magnesium stearate, stearic acid.
Opacifier is titanium dioxide.
Plasticizer is selected from Macrogol 6000, Liquid Macrogol, polyethylene glycol 400, propyl alcohol, glycerine, triacetic acid glycerine
Ester, dicarboxylic acid dimethyl ester, triacetyl glycerine.
Taste agent is selected from stevioside, citric acid.
A kind of method for preparing stomach dissolved film coating pre-mix dose, this method comprise the following steps：
(1) filmogens of above-mentioned parts by weight, antiplastering aid, plasticizer, pregelatinized starch, taste agent are taken, with purified water or
10-15 parts of ethanol uniformly mixes 1h, 35-45 DEG C of dry 5h；
(2) colouring agent, the opacifier of above-mentioned parts by weight are added in the dried mixture of upper step, after mixing 0.5-1h,
Grinder grinding 5h is transferred to, crosses 50 mesh sieves, you can obtain pre-mixing agent.
Beneficial effects of the present invention：For film coating process, successfully key is exactly to use excellent film coating for it
Material, general one complete film coating agent mainly include film forming agent, plasticizer, opacifier and toner and other auxiliary materials
Material etc., there is stringent compatibility in kind and quantity, with ensure medicine core surface energy formed one or more layers is continuous, fine and close,
Clothing film lasting and with specific function.The spilling that the film coating pre-mix dose of the present invention solves the fragrant oils such as peppermint oil becomes
The spilling of color problem, peppermint oil etc. causes colored parts agent to fail, and causes clothing film to be faded.The film coating pre-mix dose system of the present invention
There is obvious metachromatism by ten days substantially without obvious metachromatism by two days under original high humidity normal temperature condition in the coating of work.
The method of the present invention is simple, highly practical；Preparation method facilitates controllable, can directly acquire the pre-mixing agent particle and powder of suitable particle size
End.
Embodiment
The present invention is carried out with reference to embodiment explanation is explained in detail.
Embodiment 1
The stomach dissolved film coating pre-mix dose of the present invention includes the component of following parts by weight：Hypromellose 7.5g,
It is polyvinyl alcohol 7.5g, copolyvidone 7.5g, pulullan polysaccharide 7.5g, talcum powder 5g, titanium dioxide 5g, Macrogol 6000 5g, pre-
Gelling starch 5g, stevioside 0.5g, carmine lake 0.5g.
A kind of method for the stomach dissolved film coating pre-mix dose for preparing the present invention comprises the following steps：
(1) hypromellose 7.5g, polyvinyl alcohol 7.5g, copolyvidone 7.5g, pulullan polysaccharide 7.5g, talcum are taken
Powder 5g, Macrogol 6000 5g, pregelatinized starch 5g, stevioside 0.5g uniformly mix 1h, 35 DEG C of dry 5h with purified water 10g；
Sampling detection, detection project have appearance uniformity, granularity, dissolving situation, color.Appearance uniformity is detected as range estimation pre-mixing agent
Whether color is uniform, whether there is conglomeration, does not grind phenomena such as abundant；The color of mixture is uniform, and no conglomeration is qualification.Granularity Detection
It is that the pre-mixing agent of powdery is crossed into 60 mesh sieves, whether has insoluble matter on observation sieve and do not grind sufficient material；Without insoluble matter on sieve
And it is qualification not grind sufficient material；The detection of dissolving situation is observation dissolving feelings after pre-mixing agent is dissolved by solvent for use
Condition；Dissolved solution crosses 60 mesh sieves, whether has insoluble matter on observation sieve and does not grind sufficient material；On sieve without insoluble matter and
It is qualification not grind sufficient material；Enter lower step after qualification；
(2) carmine lake 0.5g, titanium dioxide 5g are added in the dried mixture of upper step, after mixing 0.5h, transfer
5h to be ground to grinder, crosses 50 mesh sieves, sampling detection, detection project is same as above, and dissolved coating solution is coated operation,
Examine whether color meets the requirements, print sample color and standard items aberration △ E ＜ 3 are qualification after coating.Inspection project is qualified
Afterwards, pack, you can obtain pre-mixing agent.
Embodiment 2
The stomach dissolved film coating pre-mix dose of the present invention includes the component of following parts by weight：Hypromellose 12.5g,
Polyvinyl alcohol 12.5g, copolyvidone 12.5g, pulullan polysaccharide 12.5g, magnesium stearate 7g, titanium dioxide 10g, polyethylene glycol
30010g, pregelatinized starch 10g, stevioside 0.5g, citric acid 0.5g, lemon yellow color lake 2g.
A kind of method for the stomach dissolved film coating pre-mix dose for preparing the present invention comprises the following steps：
(1) take hypromellose 12.5g, polyvinyl alcohol 12.5g, copolyvidone 12.5g, pulullan polysaccharide 12.5g,
Magnesium stearate 7g, Liquid Macrogol 10g, pregelatinized starch 10g, stevioside 0.5g, citric acid 0.5g, it is uniform with purified water 12g
Mix 1h, 40 DEG C of dry 5h；Sampling detection, detection project have appearance uniformity, granularity, dissolving situation, color.Appearance uniformity
Whether uniform it is detected as range estimation pre-mixing agent color, whether there is conglomeration, do not grind phenomena such as abundant；The color of mixture is uniform, no conglomeration
It is as qualified.Granularity Detection is that the pre-mixing agent of powdery is crossed 60 mesh sieves, whether has insoluble matter on observation sieve and does not grind sufficiently
Material；Sieve is upper without insoluble matter and not grind sufficient material be qualified；The detection of dissolving situation is by solvent for use by pre-mixing agent
Dissolving situation is observed after dissolving；Dissolved solution crosses 60 mesh sieves, whether has insoluble matter on observation sieve and does not grind sufficient thing
Material；Sieve is upper without insoluble matter and not grind sufficient material be qualified；Enter lower step after qualification；
(2) lemon yellow color lake 2g, titanium dioxide 10g are added in the dried mixture of upper step, after mixing 0.6h, is transferred to
Grinder grinds 5h, crosses 50 mesh sieves, sampling detection, detection project is same as above, and dissolved coating solution is coated operation, inspection
Test whether color meets the requirements, print sample color and standard items aberration △ E ＜ 3 are qualification after coating.After inspection project qualification,
Packaging, you can obtain pre-mixing agent.
Embodiment 3
The stomach dissolved film coating pre-mix dose of the present invention includes the component of following parts by weight：Hypromellose 12.5g,
Polyvinyl alcohol 7.5g, copolyvidone 5g, pulullan polysaccharide 5g, stearic acid 8g, titanium dioxide 15g, Liquid Macrogol 15g, pregelatinated
Starch 15g, citric acid 2g, light green color lake 2g.
A kind of method for the stomach dissolved film coating pre-mix dose for preparing the present invention comprises the following steps：
(1) hypromellose 12.5g, polyvinyl alcohol 7.5g, copolyvidone 5g, pulullan polysaccharide 5g, stearic acid are taken
8g, Liquid Macrogol 15g, pregelatinized starch 15g, citric acid 2g, 1h, 45 DEG C of dry 5h are uniformly mixed with ethanol 10g；Sampling
Detection, detection project have appearance uniformity, granularity, dissolving situation, color.Appearance uniformity is detected as range estimation pre-mixing agent color
It is no uniform, conglomeration is whether there is, does not grind phenomena such as abundant；The color of mixture is uniform, and no conglomeration is qualification.Granularity Detection is by powder
The pre-mixing agent of shape crosses 60 mesh sieves, whether has insoluble matter on observation sieve and does not grind sufficient material；Do not ground on sieve without insoluble matter and
It is qualification to grind sufficient material；The detection of dissolving situation is observation dissolving situation after pre-mixing agent is dissolved by solvent for use；Dissolving
Solution afterwards crosses 60 mesh sieves, whether has insoluble matter on observation sieve and does not grind sufficient material；Do not ground on sieve without insoluble matter and
Sufficient material is qualification；Enter lower step after qualification；
(2) light green color lake 2g, titanium dioxide 15g are added in the dried mixture of upper step, after mixing 1h, is transferred to grinding
Machine grinds 5h, crosses 50 mesh sieves, sampling detection, detection project is same as above, and dissolved coating solution is coated operation, examines face
Whether color meets the requirements, and print sample color and standard items aberration △ E ＜ 3 are qualification after coating.After inspection project qualification, bag
Dress, you can obtain pre-mixing agent.
Embodiment 4
The stomach dissolved film coating pre-mix dose of the present invention includes the component of following parts by weight：Hypromellose 20g, gather
Vinyl alcohol 12g, copolyvidone 8g, pulullan polysaccharide 8g, talcum powder 10g, titanium dioxide 20g, triacetyl glycerine 20g, pregelatinated
Starch 20g, stevioside 5g, Brilliant blue aluminum lake 5g.
A kind of method for the stomach dissolved film coating pre-mix dose for preparing the present invention comprises the following steps：
(1) take hypromellose 20g, polyvinyl alcohol 12g, copolyvidone 8g, pulullan polysaccharide 8g, talcum powder 10g,
Triacetyl glycerine 20g, pregelatinized starch 20g, stevioside 5g, 1h, 45 DEG C of dry 5h are uniformly mixed with ethanol 15g；Sampling inspection
Survey, detection project has appearance uniformity, granularity, dissolving situation, color.Whether appearance uniformity is detected as range estimation pre-mixing agent color
Uniformly, conglomeration is whether there is, does not grind phenomena such as abundant；The color of mixture is uniform, and no conglomeration is qualification.Granularity Detection is by powdery
Pre-mixing agent cross 60 mesh sieves, whether have insoluble matter on observation sieve and do not grind sufficient material；Do not ground on sieve without insoluble matter and
Sufficient material is qualification；The detection of dissolving situation is observation dissolving situation after pre-mixing agent is dissolved by solvent for use；After dissolving
Solution cross 60 mesh sieves, whether have insoluble matter on observation sieve and do not grind sufficient material；Filled on sieve without insoluble matter and not grinding
The material divided is qualification；Enter lower step after qualification；
(2) Brilliant blue aluminum lake 5g, titanium dioxide 20g are added in the dried mixture of upper step, after mixing 1h, is transferred to and grinds
Grinding machine grinds 5h, crosses 50 mesh sieves, sampling detection, detection project is same as above, and dissolved coating solution is coated operation, is examined
Whether color meets the requirements, and print sample color and standard items aberration △ E ＜ 3 are qualification after coating.After inspection project qualification, bag
Dress, you can obtain pre-mixing agent.
Determine that the experiment detailed process of the optimal component of stomach dissolved film coating pre-mix dose of the present invention is as follows：
Experiment 1
For the accuracy of guarantee test, contrast test is using compound Radix zanthoxyli lozenge as coating plain piece.(compound two sides
Pin lozenge main component：FRUCTUS TERMINALIAE IMMATURUS, Radix zanthoxyli, subprostrate sophora, menthol, peppermint oil dementholized.)
Verify that colouring agent, taste agent overflow compound Radix zanthoxyli lozenge the influence of discoloration.
Basic components are hypromellose, talcum powder, titanium dioxide, polyethylene glycol, colouring agent.
Transparent white, plain piece true qualities (shallow brown green), tongue color (pink), green are done respectively.
The stevioside and minty taste for adding different proportion are done respectively.
Above-mentioned test specimen is done into room temperature nude film respectively and places experiment, specific experimental phenomena such as table 1：
The naked color of room temperature of 1 test specimen of table places the situation result table of experiment
As shown in Table 1, compound Radix zanthoxyli lozenge is coated different color fading degree and will be different, close with plain piece
Color fading is relatively slow, and the more colour fadings of taste adding proportion are rapider.
I groups are used to be tested for experimental basis control group according to above-mentioned conclusion (of pressure testing).
Experiment 2
Compound Radix zanthoxyli lozenge peppermint oil spilling discoloration problem is solved by varying the species and ratio of filmogen.Mainly
Subjects for hypromellose, polyvinyl alcohol, ethyl cellulose, povidone, polyacrylic resinⅣ etc..Use mesh
Plasticizer of the preceding blanket polyethylene glycol as pre-stage test.Main component is titanium dioxide, talcum powder, poly- second in formula
Glycol, carmine lake and filmogen.
A is using hypromellose as main filmogen
B is using polyvinyl alcohol as main filmogen
C is using ethyl cellulose as main filmogen
D is using povidone as main filmogen
Above-mentioned testing program is configured to solution respectively to be coated, print carries out room temperature nude film and places experiment after coating
(20 DEG C, 3 months of temperature) and accelerated test (40 ± 2 DEG C of temperature, humidity 75 ± 5%, 6 months).Using X-Rite color difference meters into
Row detection, specific data such as table 2：
Print carries out the result table that room temperature nude film places experiment and accelerated test after table 2 is coated
Drawn a conclusion by above-mentioned test data with hypromellose, polyvinyl alcohol is the test group of main filmogen
In room temperature nude film places experiment (20 DEG C, 3 months of temperature) and accelerated test (40 ± 2 DEG C of temperature, humidity 75 ± 5%, 6 months)
Chromatic aberration is relatively small.Therefore select above two material be main filmogen, with suitable plasticizer and other into
Divide (experiment is probed into below) compatibility to reach and solve the problems, such as that compound Radix zanthoxyli lozenge overflows discoloration.
Probe into and what hypromellose, polyvinyl alcohol were compatible can effectively solve the problem that compound Radix zanthoxyli lozenge overflows change
The plasticizer and other compositions of color, to determine final test recipe.
Because polyvinyl alcohol dissolves well in water, (mol/mol) coating solution of alcoholysis degree 87~89% using water or low alcohol as
Solvent.Main experimental object is：Copolyvidone, triacetyl glycerine, PVP K30, polyethylene glycol, glycerine etc..Specific experiment
Compatibility program such as table 3：
Table 3 specifically tests compatibility program
Remaining component is formulated using hypromellose, polyvinyl alcohol, carmine lake, talcum powder, titanium dioxide, stevia rebaudianum
Sugar.Show that the effect of B schemes is worst after being coated experiment according to above-mentioned definite scheme, nude film is placed half a day, that is, faded
Phenomenon, next step experiment is carried out according to this conclusion.
Table 4 specifically tests compatibility program
By compatibility mechanism two-by-two, as shown in Table 4, F group effects are best, and accelerated test can delay compared with other group spilling times
The 1-2 months.And overflowed slowly compared with other groups, aberration is average within Δ Ε * 5.5 after 6 months.
Easily there is spillover since peppermint oil chance is hot and humid, to make label rapid film formation, when shortening bag is made
Between, oozed out with reducing peppermint oil from label.Select hypromellose, polyvinyl alcohol, copolyvidone, pulullan polysaccharide phase
It is combined as filmogen and effectively solves the problems, such as this.
Compound Radix zanthoxyli lozenge inherently contains a large amount of peppermints and other tastes, therefore in order to meet the mouthfeel need of buccal tablet
Ask, it is necessary to add suitable taste agent in coating, determine that the taste agent of addition is citric acid through overtesting, stevioside, Pu Lu
Blue polysaccharide (because its is pleasantly sweet therefore can be listed herein as taste agent) specific additive amount is appropriate for citric acid, and appropriate stevioside is general
Shandong orchid polysaccharide is appropriate.
It can voluntarily select for colouring agent, but learnt according to Part I experiment closer to plain piece color according to the actual requirements
Stability is higher.Some opacifiers, such as titanium dioxide are added in right amount, play the role of completely cutting off ultraviolet and fixation.
In conclusion determine that experiment optimization formula is hypromellose, polyvinyl alcohol, gathers according to experiment above is final
Ethylene glycol, copolyvidone, citric acid, pulullan polysaccharide, stevioside, titanium dioxide, talcum powder, colouring agent, pregelatinized starch.
The obtained formula amount of being amplified experiment coating will be tested, and carry out associated verification experiment.Coating design parameter is shown in
Table 5.
Print does room temperature nude film and places experiment (20 DEG C, 3 months of temperature) and accelerated test (temperature 40 ± 2 respectively after coating
DEG C, humidity 75 ± 5%, 6 months), test effect is good, and room temperature nude film, which is placed 3 months, has slight discolouration phenomena (to belong to and just often occur
As), without softening, spillover, color was without significant change in 6 months for accelerated test.Room temperature nude film is placed couple of days and is taken off than before
Color, which overflows to have, to be obviously improved.This formula is applied to profound wheat citrus lozenge, water melon frost guttural tablets, honeysuckle lozenge Ai Kangsha
Spine buccal tablet etc., there is good result.Therefore it may determine that the test recipe for preventing compound Radix zanthoxyli buccal tablet class from containing
The buccal tablet of volatile oil component has good coating effect.
Table 5 is coated design parameter
Presently preferred embodiments of the present invention, is not intended to limit the invention, all to be made in substantive content of the present invention
Any modification, equivalent substitution and simple modifications etc., should all be included in the protection scope of the present invention.
Claims (5)
1. a kind of stomach dissolved film coating pre-mix dose, it is characterised in that the pre-mixing agent includes the component of following parts by weight：Into membrane material
30-50 parts of material, 5-10 parts of antiplastering aid, 5-15 parts of opacifier, 5-20 parts of plasticizer, 5-20 parts of pregelatinized starch, taste agent 0.5-5
Part, 0.5-5 parts of colouring agent；Filmogen is made of the component of following parts by weight：1-5 parts of hypromellose, polyvinyl alcohol
1-3 parts, 1-2 parts of copolyvidone, 1-2 parts of pulullan polysaccharide；Plasticizer is Macrogol 6000 or Liquid Macrogol.
2. stomach dissolved film coating pre-mix dose according to claim 1, it is characterised in that antiplastering aid is selected from talcum powder, hard
Fatty acid magnesium, stearic acid.
3. stomach dissolved film coating pre-mix dose according to claim 1, it is characterised in that opacifier is titanium dioxide.
4. stomach dissolved film coating pre-mix dose according to claim 1, it is characterised in that taste agent is selected from stevioside, lemon
Lemon acid.
A kind of 5. method for preparing the stomach dissolved film coating pre-mix dose described in 1-4 any claims, it is characterised in that the party
Method comprises the following steps：
(1) filmogens of above-mentioned parts by weight, antiplastering aid, plasticizer, pregelatinized starch, taste agent are taken, with purified water or ethanol
10-15 parts uniformly mix 1h, 35-45 DEG C of dry 5h；
(2) colouring agent, the opacifier of above-mentioned parts by weight are added in the dried mixture of upper step, after mixing 0.5-1h, transfer
5h is ground to grinder, crosses 50 mesh sieves, you can obtain pre-mixing agent.
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| CN106214658B (en) * | 2016-08-29 | 2019-05-03 | 北京英茂药业有限公司 | A kind of compound coating pre-mixing agent and preparation method thereof |
| CN106310284A (en) * | 2016-10-25 | 2017-01-11 | 连云港康力特药业有限公司 | Water-soluble intestine-dissolving film coating premixed preparation and preparation method thereof |
| CN112472813A (en) * | 2016-10-28 | 2021-03-12 | 北京药源世纪生物科技有限公司 | Cellulose red algae polysaccharide film coating premix and preparation method thereof |
| CN110018036A (en) * | 2019-04-26 | 2019-07-16 | 安阳天助药业有限责任公司 | A kind of method for quickly detecting of solid powder material color difference |
| CN110101678B (en) * | 2019-04-26 | 2021-04-30 | 安阳天助药业有限责任公司 | Improved coating premix containing magnesium stearate and preparation method |
| CN110585160A (en) * | 2019-09-23 | 2019-12-20 | 天津嘉汇捷瑞医药科技有限公司 | Film coating premix applied to extract tablets and preparation method thereof |
| CN116570572A (en) * | 2023-05-23 | 2023-08-11 | 曲阜贝斯迪生物医药有限公司 | Gastric-soluble film coating premix and preparation method thereof |
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