CN104958272A - Gastric-soluble film coating premixed agent and preparation method thereof - Google Patents
Gastric-soluble film coating premixed agent and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a gastric-soluble film coating premixed agent. The gastric-soluble film coating premixed agent comprises the following components in parts by weight: 30-50 parts of a film-forming material, 5-10 parts of an anti-sticking agent, 5-15 parts of a light-screening agent, 5-20 parts of a plasticizer, 5-20 pats of pregelatinized starch, 0.5-5 parts of a flavour agent and 0.5-5 parts of a colouring agent. A preparation method of the gastric-soluble film coating premixed agent comprises the following steps: (1) weighing the film-forming material, the anti-sticking agent, the plasticizer, the pregelatinized starch and the flavour agent in parts by weight, uniformly mixing with 10-15 parts by weight of purified water or ethyl alcohol for one hour, and drying for 5 hours at the temperature of 35-45 DEG C; and (2) adding the colouring agent and the light-screening agent in parts by weight into the mixture obtained in the step (1), mixing for 0.5-1 hour, transferring to a grinding mill for grinding for 5 hours, and sieving by virtue of a 50-mesh sieve, thus obtaining the gastric-soluble film coating premixed agent. A coating prepared from the film coating premixed agent does not change colour in ten days instead of the original two days under the high-humidity and normal temperature conditions; besides, the preparation method of the film coating premixed agent is simple, strong in practicability, convenient and controllable, and premixed agent granules and powder with appropriate granularity can be directly obtained.
Description
Technical field
The invention belongs to drug coating and make formula and Technology field, be specifically related to a kind of stomach dissolved film coating pre-mix dose and preparation method thereof.
Background technology
The film-coated technique of China is applied and is started late, the eighties in 20th century, some large-scale pharmacy corporations of China just start to introduce this technology, in the last few years, along with film-coated technique developing rapidly in China's preparation is produced, some grow development, for the extensive use of film-coated technique in preparation industry serves positive impetus to apply this technology with the professional technique company developing the relevant coating material of operation as emerged rapidly in large numbersBamboo shoots after a spring rain.
At present buccal tablet on the market adds taste and bright-colored beautiful mostly.But due to complexity and the multiformity of the composition of buccal tablet element sheet own, film-coated technique is difficult to solve the spilling metachromatism of Herba Menthae wet goods aromatic oil class in plain sheet.The present invention well solves this difficult problem, and the spilling variable color of Herba Menthae wet goods aromatic oil class causes primarily of the following aspects.(1) Oleum menthae addition is excessive, causes coating process underpants film to cover irregular, the series of problems such as adhesive force degradation; (2) in thin film pre-mixing agent, the interpolation of taste agent is excessive, causes the film property of clothing film to reduce, affects the stability of clothing film, cause Oleum menthae to overflow; (3) packaging technique existing problems, the dissolvent solid content of coating solution and weightening finish, sheet bed tempertaure during coating, discharge rate etc.; (4) problem such as selection and adaptability of the raw material such as coloring agent, film former.
Summary of the invention
The spilling color-change technology problem of Herba Menthae oils aromatic oil can not be prevented completely in order to solve above-mentioned film coating, the invention provides a kind of satisfied film coating pre-mix dose required containing the buccal tablet of Herba Menthae oils aromatic oil, also disclose the preparation method of this film coating pre-mix dose simultaneously.
The invention provides a kind of stomach dissolved film coating pre-mix dose, this pre-mixing agent comprises the component of following weight portion: filmogen 30-50 part, antiplastering aid 5-10 part, opacifier 5-15 part, plasticizer 5-20 part, pregelatinized Starch 5-20 part, taste agent 0.5-5 part, coloring agent 0.5-5 part.
Filmogen comprises the component of following weight portion: hydroxypropyl methylcellulose 1-5 part, polyvinyl alcohol 1-3 part, copolyvidone 1-2 part, pulullan polysaccharide 1-2 part.
Antiplastering aid is selected from Pulvis Talci, magnesium stearate, stearic acid.
Opacifier is titanium dioxide.
Plasticizer is selected from polyethylene glycol 6000, Liquid Macrogol, PEG400, propanol, glycerol, glyceryl triacetate, dicarboxylic acid dimethyl ester, triacetyl glycerine.
Taste agent is selected from stevioside, citric acid.
Prepare a method for stomach dissolved film coating pre-mix dose, the method comprises the following steps:
(1) filmogen of above-mentioned weight portion, antiplastering aid, plasticizer, pregelatinized Starch, taste agent is got, with purified water or ethanol 10-15 part Homogeneous phase mixing 1h, 35-45 DEG C of dry 5h;
(2) in the dried mixture of upper step, add coloring agent, the opacifier of above-mentioned weight portion, after mixing 0.5-1h, be transferred to grinder grinding 5h, cross 50 mesh sieves, can pre-mixing agent be obtained.
Beneficial effect of the present invention: for film coating process, its successful key is exactly use excellent thin film coating material, a general complete film coating agent mainly comprises film former, plasticizer, opacifier and toner and other auxiliary material etc., in kind with quantitatively there is strict compatibility, with ensure medicated core surface energy formed one or more layers continuously, fine and close, lasting and there is the clothing film of specific function.Film coating pre-mix dose of the present invention solves the spilling discoloration problem of Herba Menthae wet goods aromatic oil class, and the spilling of Herba Menthae wet goods makes colored parts agent lose efficacy, and causes clothing film to fade.Namely obvious metachromatism is there is by ten days substantially without obvious metachromatism in the coating that film coating pre-mix dose of the present invention makes by under original high humidity normal temperature condition two days.Method of the present invention is simple, practical; Preparation method facilitates controlled, directly can obtain pre-mixing agent granule and the powder of suitable particle size.
Detailed description of the invention
Below in conjunction with embodiment, in detail explanation is explained to the present invention.
Embodiment 1
Stomach dissolved film coating pre-mix dose of the present invention comprises the component of following weight portion: hydroxypropyl methylcellulose 7.5g, polyvinyl alcohol 7.5g, copolyvidone 7.5g, pulullan polysaccharide 7.5g, Pulvis Talci 5g, titanium dioxide 5g, polyethylene glycol 6000 5g, pregelatinized Starch 5g, stevioside 0.5g, carmine lake 0.5g.
A kind of method preparing stomach dissolved film coating pre-mix dose of the present invention comprises the following steps:
(1) hydroxypropyl methylcellulose 7.5g, polyvinyl alcohol 7.5g, copolyvidone 7.5g, pulullan polysaccharide 7.5g, Pulvis Talci 5g, polyethylene glycol 6000 5g, pregelatinized Starch 5g, stevioside 0.5g and purified water 10g Homogeneous phase mixing 1h is got, 35 DEG C of dry 5h; Sampling detects, and test item has outward appearance uniformity, granularity, dissolving situation, color.Whether outward appearance uniformity is detected as range estimation pre-mixing agent color even, with or without conglomeration, does not grind the phenomenons such as abundant; The color even of mixture, it is qualified to be without conglomeration.Granularity Detection is that the pre-mixing agent of powdery is crossed 60 mesh sieves, observes on sieve and whether has insoluble matter and do not grind sufficient material; On sieve without insoluble matter and do not grind sufficient material be qualified; It is observe dissolving situation after being dissolved by solvent for use by pre-mixing agent that dissolving situation detects; Solution after dissolving crosses 60 mesh sieves, observes on sieve and whether has insoluble matter and do not grind sufficient material; On sieve without insoluble matter and do not grind sufficient material be qualified; Lower step is entered after qualified;
(2) in the dried mixture of upper step, carmine lake 0.5g, titanium dioxide 5g is added, after mixing 0.5h, be transferred to grinder grinding 5h, cross 50 mesh sieves, sampling detects, and test item is the same, and the coating solution after dissolving is carried out coating operations, inspection color whether meet the requirements, after coating print sample color and standard substance aberration △ E < 3 be qualified.After inspection item are all qualified, packaging, can obtain pre-mixing agent.
Embodiment 2
Stomach dissolved film coating pre-mix dose of the present invention comprises the component of following weight portion: hydroxypropyl methylcellulose 12.5g, polyvinyl alcohol 12.5g, copolyvidone 12.5g, pulullan polysaccharide 12.5g, magnesium stearate 7g, titanium dioxide 10g, Liquid Macrogol 10g, pregelatinized Starch 10g, stevioside 0.5g, citric acid 0.5g, lemon yellow color lake 2g.
A kind of method preparing stomach dissolved film coating pre-mix dose of the present invention comprises the following steps:
(1) hydroxypropyl methylcellulose 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 is got, with purified water 12g Homogeneous phase mixing 1h, 40 DEG C of dry 5h; Sampling detects, and test item has outward appearance uniformity, granularity, dissolving situation, color.Whether outward appearance uniformity is detected as range estimation pre-mixing agent color even, with or without conglomeration, does not grind the phenomenons such as abundant; The color even of mixture, it is qualified to be without conglomeration.Granularity Detection is that the pre-mixing agent of powdery is crossed 60 mesh sieves, observes on sieve and whether has insoluble matter and do not grind sufficient material; On sieve without insoluble matter and do not grind sufficient material be qualified; It is observe dissolving situation after being dissolved by solvent for use by pre-mixing agent that dissolving situation detects; Solution after dissolving crosses 60 mesh sieves, observes on sieve and whether has insoluble matter and do not grind sufficient material; On sieve without insoluble matter and do not grind sufficient material be qualified; Lower step is entered after qualified;
(2) in the dried mixture of upper step, lemon yellow color lake 2g, titanium dioxide 10g is added, after mixing 0.6h, be transferred to grinder grinding 5h, cross 50 mesh sieves, sampling detects, and test item is the same, and the coating solution after dissolving is carried out coating operations, inspection color whether meet the requirements, after coating print sample color and standard substance aberration △ E < 3 be qualified.After inspection item are all qualified, packaging, can obtain pre-mixing agent.
Embodiment 3
Stomach dissolved film coating pre-mix dose of the present invention comprises the component of following weight portion: hydroxypropyl methylcellulose 12.5g, polyvinyl alcohol 7.5g, copolyvidone 5g, pulullan polysaccharide 5g, stearic acid 8g, titanium dioxide 15g, Liquid Macrogol 15g, pregelatinized Starch 15g, citric acid 2g, light green color lake 2g.
A kind of method preparing stomach dissolved film coating pre-mix dose of the present invention comprises the following steps:
(1) hydroxypropyl methylcellulose 12.5g, polyvinyl alcohol 7.5g, copolyvidone 5g, pulullan polysaccharide 5g, stearic acid 8g, Liquid Macrogol 15g, pregelatinized Starch 15g, citric acid 2g is got, with ethanol 10g Homogeneous phase mixing 1h, 45 DEG C of dry 5h; Sampling detects, and test item has outward appearance uniformity, granularity, dissolving situation, color.Whether outward appearance uniformity is detected as range estimation pre-mixing agent color even, with or without conglomeration, does not grind the phenomenons such as abundant; The color even of mixture, it is qualified to be without conglomeration.Granularity Detection is that the pre-mixing agent of powdery is crossed 60 mesh sieves, observes on sieve and whether has insoluble matter and do not grind sufficient material; On sieve without insoluble matter and do not grind sufficient material be qualified; It is observe dissolving situation after being dissolved by solvent for use by pre-mixing agent that dissolving situation detects; Solution after dissolving crosses 60 mesh sieves, observes on sieve and whether has insoluble matter and do not grind sufficient material; On sieve without insoluble matter and do not grind sufficient material be qualified; Lower step is entered after qualified;
(2) in the dried mixture of upper step, light green color lake 2g, titanium dioxide 15g is added, after mixing 1h, be transferred to grinder grinding 5h, cross 50 mesh sieves, sampling detects, and test item is the same, and the coating solution after dissolving is carried out coating operations, inspection color whether meet the requirements, after coating print sample color and standard substance aberration △ E < 3 be qualified.After inspection item are all qualified, packaging, can obtain pre-mixing agent.
Embodiment 4
Stomach dissolved film coating pre-mix dose of the present invention comprises the component of following weight portion: hydroxypropyl methylcellulose 20g, polyvinyl alcohol 12g, copolyvidone 8g, pulullan polysaccharide 8g, Pulvis Talci 10g, titanium dioxide 20g, triacetyl glycerine 20g, pregelatinized Starch 20g, stevioside 5g, Brilliant blue aluminum lake 5g.
A kind of method preparing stomach dissolved film coating pre-mix dose of the present invention comprises the following steps:
(1) hydroxypropyl methylcellulose 20g, polyvinyl alcohol 12g, copolyvidone 8g, pulullan polysaccharide 8g, Pulvis Talci 10g, triacetyl glycerine 20g, pregelatinized Starch 20g, stevioside 5g is got, with ethanol 15g Homogeneous phase mixing 1h, 45 DEG C of dry 5h; Sampling detects, and test item has outward appearance uniformity, granularity, dissolving situation, color.Whether outward appearance uniformity is detected as range estimation pre-mixing agent color even, with or without conglomeration, does not grind the phenomenons such as abundant; The color even of mixture, it is qualified to be without conglomeration.Granularity Detection is that the pre-mixing agent of powdery is crossed 60 mesh sieves, observes on sieve and whether has insoluble matter and do not grind sufficient material; On sieve without insoluble matter and do not grind sufficient material be qualified; It is observe dissolving situation after being dissolved by solvent for use by pre-mixing agent that dissolving situation detects; Solution after dissolving crosses 60 mesh sieves, observes on sieve and whether has insoluble matter and do not grind sufficient material; On sieve without insoluble matter and do not grind sufficient material be qualified; Lower step is entered after qualified;
(2) in the dried mixture of upper step, Brilliant blue aluminum lake 5g, titanium dioxide 20g is added, after mixing 1h, be transferred to grinder grinding 5h, cross 50 mesh sieves, sampling detects, and test item is the same, and the coating solution after dissolving is carried out coating operations, inspection color whether meet the requirements, after coating print sample color and standard substance aberration △ E < 3 be qualified.After inspection item are all qualified, packaging, can obtain pre-mixing agent.
Determine that the test 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 all adopts compound Radix zanthoxyli lozenge as coating element sheet.(compound Radix zanthoxyli lozenge main component: FRUCTUS TERMINALIAE IMMATURUS, Radix Zanthoxyli, Radix Sophorae Tonkinensis, Mentholum, Oleum menthae.)
Checking coloring agent, taste agent overflow the impact of variable color on compound Radix zanthoxyli lozenge.
Basic components is hydroxypropyl methylcellulose, Pulvis Talci, titanium dioxide, Polyethylene Glycol, coloring agent.
Do transparent white respectively, plain sheet true qualities (shallow brown green), tongue color (pink), green.
Do the stevioside and minty taste that add different proportion respectively.
Above-mentioned test specimen is done respectively room temperature nude film and place test, concrete experimental phenomena is as table 1:
The naked color of room temperature of table 1 test specimen places the situation result table of test
As shown in Table 1, the different color fading degree of compound Radix zanthoxyli lozenge coating can be different, and the color fading close with plain sheet is relatively slow, and taste adding proportion is faded rapider more.
According to above-mentioned conclusion (of pressure testing) employing I group for experimental basis matched group is tested.
Experiment 2
Solve compound Radix zanthoxyli lozenge Oleum menthae by the kind and ratio changing over membrane material and overflow discoloration problem.Main subjects is hydroxypropyl methylcellulose, polyvinyl alcohol, ethyl cellulose, polyvidone, polyacrylic resin Ⅳ etc.Use current blanket Polyethylene Glycol as the plasticizer of pre-stage test.In formula, main component is titanium dioxide, Pulvis Talci, Polyethylene Glycol, carmine lake and filmogen.
A is main filmogen with hydroxypropyl methylcellulose
B is main filmogen with polyvinyl alcohol
C is main filmogen with ethyl cellulose
D is main filmogen with polyvidone
Above-mentioned testing program is mixed with solution respectively and carries out coating, after coating, print carries out room temperature nude film placement test (temperature 20 DEG C, 3 months) and accelerated test (temperature 40 ± 2 DEG C, humidity 75 ± 5%, 6 months).Use X-Rite color difference meter to detect, concrete data are as table 2:
After table 2 coating, print carries out the result table that room temperature nude film places test and accelerated test
Reach a conclusion with hydroxypropyl methylcellulose by above-mentioned test data, polyvinyl alcohol is that the test group of main filmogen places test (temperature 20 DEG C at room temperature nude film, 3 months) and accelerated test (temperature 40 ± 2 DEG C, humidity 75 ± 5%, 6 months) in chromatic aberration relatively little.Therefore above-mentioned bi-material is selected to be main filmogen, reaching and solve with suitable plasticizer and other compositions (below test probe into) compatibility the problem that compound Radix zanthoxyli lozenge overflows variable color.
Probe into and compatiblely with hydroxypropyl methylcellulose, polyvinyl alcohol effectively can solve plasticizer and other compositions that compound Radix zanthoxyli lozenge overflows variable color, to determine final test recipe.
Because polyvinyl alcohol dissolves well in water, alcoholysis degree 87 ~ 89% (mol/mol) coating solution is using water or low alcohol as solvent.Main experimental object is: copolyvidone, triacetyl glycerine, PVP K30, Polyethylene Glycol, glycerol etc.Concrete test compatibility program is as table 3:
Table 3 specifically tests compatibility program
All the other components of formula adopt hydroxypropyl methylcellulose, polyvinyl alcohol, carmine lake, Pulvis Talci, titanium dioxide, stevioside.Determine to show that the effect of B scheme is the poorest after scheme carries out coating test according to above-mentioned, nude film is placed and is namely occurred discolouration phenomena half a day, carries out next step experiment according to this conclusion.
Table 4 specifically tests compatibility program
By compatibility mechanism between two, as shown in Table 4, F group effect is best, and comparatively other group spilling times can delay the 1-2 month to accelerated test.And comparatively other groups are overflowed slowly, after 6 months, aberration is on average within Δ Ε * 5.5.
Easily there is spillover because Oleum menthae chance is hot and humid, therefore will make label rapid film formation, shorten bag and make the time, ooze out from label to reduce Oleum menthae.Select hydroxypropyl methylcellulose, polyvinyl alcohol, copolyvidone, pulullan polysaccharide to combine and effectively solve this problem as filmogen.
Compound Radix zanthoxyli lozenge is inherently containing a large amount of Herba Menthae and other tastes, therefore in order to meet the mouthfeel demand of buccal tablet, need in coating, add appropriate taste agent, determine that the taste agent added is citric acid through overtesting, stevioside, pulullan polysaccharide (because it is pleasantly sweet therefore can be used as taste agent at this and list) concrete addition is that citric acid is appropriate, and stevioside is appropriate, and pulullan polysaccharide is appropriate.
Can select voluntarily according to the actual requirements for coloring agent, but learn close to plain sheet colour stability higher according to Part I test.Some opacifiers of appropriate interpolation, as titanium dioxide etc., have the effect of isolated ultraviolet and fixation.
In sum, finally determine that test optimization formula is hydroxypropyl methylcellulose, polyvinyl alcohol, Polyethylene Glycol, copolyvidone, citric acid, pulullan polysaccharide, stevioside, titanium dioxide, Pulvis Talci, coloring agent, pregelatinized Starch according to above test.
Amplification quantity test coating is carried out, line correlation demonstration test of going forward side by side by testing the formula obtained.Coating design parameter is in table 5.
After coating, print does room temperature nude film respectively and places test (temperature 20 DEG C, 3 months) and accelerated test (temperature 40 ± 2 DEG C, humidity 75 ± 5%, 6 months), test effect is good, and room temperature nude film is placed slight discolouration phenomena (belonging to normal phenomenon) for 3 months, and accelerated test 6 months is without deliquescing, spillover, color is without significant change.Comparatively, room temperature nude film places couple of days spilling of namely fading obvious improvement.This formula is applied to profound wheat Citrus buccal tablet, watermelon crystal guttural tablets, honeysuckle lozenge Ai Kang Fructus Hippophae buccal tablet etc., all has good result.Therefore can judge that this test recipe has good coating effect for the buccal tablet preventing compound Radix zanthoxyli buccal tablet class from containing volatile oil composition.
Table 5 coating design parameter
Preferred embodiment of the present invention, not in order to limit the present invention, all do in flesh and blood of the present invention any amendment, equivalent to replace and simple modifications etc., all should be included within protection scope of the present invention.
Claims (7)
1. a stomach dissolved film coating pre-mix dose, it is characterized in that, this pre-mixing agent comprises the component of following weight portion: filmogen 30-50 part, antiplastering aid 5-10 part, opacifier 5-15 part, plasticizer 5-20 part, pregelatinized Starch 5-20 part, taste agent 0.5-5 part, coloring agent 0.5-5 part.
2. stomach dissolved film coating pre-mix dose according to claim 1, is characterized in that, filmogen comprises the component of following weight portion: hydroxypropyl methylcellulose 1-5 part, polyvinyl alcohol 1-3 part, copolyvidone 1-2 part, pulullan polysaccharide 1-2 part.
3. stomach dissolved film coating pre-mix dose according to claim 1, is characterized in that, antiplastering aid is selected from Pulvis Talci, magnesium stearate, stearic acid.
4. stomach dissolved film coating pre-mix dose according to claim 1, is characterized in that, opacifier is titanium dioxide.
5. stomach dissolved film coating pre-mix dose according to claim 1, is characterized in that, plasticizer is selected from polyethylene glycol 6000, Liquid Macrogol, PEG400, propanol, glycerol, glyceryl triacetate, dicarboxylic acid dimethyl ester, triacetyl glycerine.
6. stomach dissolved film coating pre-mix dose according to claim 1, is characterized in that, taste agent is selected from stevioside, citric acid.
7. prepare a method for the stomach dissolved film coating pre-mix dose described in the arbitrary claim of 1-6, it is characterized in that, the method comprises the following steps:
(1) filmogen of above-mentioned weight portion, antiplastering aid, plasticizer, pregelatinized Starch, taste agent is got, with purified water or ethanol 10-15 part Homogeneous phase mixing 1h, 35-45 DEG C of dry 5h;
(2) in the dried mixture of upper step, add coloring agent, the opacifier of above-mentioned weight portion, after mixing 0.5-1h, be transferred to grinder grinding 5h, cross 50 mesh sieves, can pre-mixing agent be obtained.
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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 |
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