CN105106968B - 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 PDF

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CN105106968B
CN105106968B CN201510630022.0A CN201510630022A CN105106968B CN 105106968 B CN105106968 B CN 105106968B CN 201510630022 A CN201510630022 A CN 201510630022A CN 105106968 B CN105106968 B CN 105106968B
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agent
film coating
colloid
coating
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CN105106968A (en
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陈佩英
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BEIJING YINGMAO PHARMACEUTICAL Co Ltd
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BEIJING YINGMAO PHARMACEUTICAL Co Ltd
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Abstract

The invention discloses a kind of stomach dissolved film coating pre-mix dose and preparation method thereof, the pre-mixing agent includes the component of following mass parts:30 50 parts of filmogen, 10 20 parts of antiplastering aid, 0.5 5 parts of colouring agent, 20 30 parts of covering agent, 5 15 parts of plasticizer, 13 parts of colloid MCC.Its preparation method:(1) filmogen, antiplastering aid, plasticizer, the colloid MCC of above-mentioned mass parts are taken, uniformly 0.8 1h, 35 45 DEG C of dry 5h are mixed with purified water or ethanol part;(2) colouring agent, the covering agent of above-mentioned mass parts are added in the dried mixture of upper step, after mixing 0.5 1h, grinder grinds 4 5h, crosses 50 mesh sieves, produces pre-mixing agent.Colloid MCC in pre-mixing agent of the present invention improves the stability of coating solution, reduces coating solution settling rate effect and is better than by addition thickener to alleviate the coating solution rate of settling, and coating process is more smooth, and faster, unilateral effect is finer and smoother after coating for coating speed.Colloid MCC is to play a part of dispersant and protecting colloid with microcrystalline cellulose with main body, sodium carboxymethylcellulose.

Description

A kind of stomach dissolved film coating pre-mix dose and preparation method thereof
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
In China, the application of film-coated technique is in the process of accelerated development, and the market prospects of film coating are very wide Wealthy, the perfect raising innovation of coating material and packaging technique is also imperative.It is to lean on film bag to have increasing pharmaceutical preparation Clothing come cover its abnormal taste, cover it is various not by the colors liked of masses.Want to have reached using film-coated technique Mainly there is both direction during complete hiding label this mesh of color.First, increase coating weight gain;Second, the coating using high covering power Product.Pharmacy corporation then more favor high covering power coated product come reach cover label purpose.Because wrapped relative to increase Clothing increase weight, using high covering power coated product on Coating times it is shorter, coated product usage amount is less, cost of drugs is lower. As film-coating product research and development side, its main technological means is exactly to be reached by increasing the ratio of covering effect in product To this purpose, these compositions are largely made up of the insoluble raw material such as titanium dioxide, talcum powder.More particulate matter meetings Settling rate is accelerated after causing to be configured to coating solution, to bringing very big influence in coating process and on coating effect.
Speed and the particle diameter settled according to sedimentation theory (Stokes theory) it is square directly proportional, be situated between with continuous phase The viscosity of matter is inversely proportional.Because when film coating pre-mix dose is developed, insoluble titanium dioxide, talcum powder are all in composition Supplier will also be passed through using process in addition in process of production Task-size Controlling to very small material and the work such as grind Sequence, so the method that uses was addition thickener to improve dielectric viscosity in research coating solution free settling problem in the past.But cross What high coating fluid viscosity was brought therewith is that coating process atomization is not thorough, blocks up rifle;A series of problems, such as unilateral coarse after coating.
The content of the invention
Only the rate of settling is reduced by increase liquid viscosity to solve above-mentioned high cover film coating easily cause that coating is not smooth, wraps The unilateral technical problem such as coarse after clothing, the invention provides a kind of stomach dissolution type film-coating premixing for including colloid MCC stabilizers Agent and preparation method thereof.
The invention provides a kind of stomach dissolved film coating pre-mix dose, the pre-mixing agent includes the component of following mass parts:Into Membrane material 30-50 parts, antiplastering aid 10-20 parts, colouring agent 0.5-5 parts, covering agent 20-30 parts, plasticizer 5-15 parts, colloid MCC 1-3 parts;
Wherein, colloid MCC includes microcrystalline cellulose and sodium carboxymethylcellulose, microcrystalline cellulose and sodium carboxymethylcellulose Mass ratio be 1-1.5:8.5-9.
Preferably, filmogen includes the component of following mass parts:HPMC 1-5 parts, polyvinyl alcohol 1-3 Part, copolyvidone 1-2 parts.
Preferably, antiplastering aid is any one in talcum powder, magnesium stearate, stearic acid.
Preferably, covering agent is titanium dioxide.
Preferably, plasticizer is Macrogol 6000, Liquid Macrogol, polyethylene glycol 400, propyl alcohol, glycerine, triacetic acid Any one in glyceride, dicarboxylic acid dimethyl ester, triacetyl glycerine.
A kind of method for preparing stomach dissolved film coating pre-mix dose of the present invention, this method comprise the following steps:
(1) filmogen 30-50 parts, antiplastering aid 10-20 parts, plasticizer 5-15 parts, colloid MCC1-3 parts are taken, with purified water 6-12 parts, ethanol 2-4 parts uniformly mix 0.8-1h, 35-45 DEG C of dry 4-5h;
(2) colouring agent 0.5-5 parts, opacifier 20-30 parts are added in the dried mixture of upper step, mixes 0.5-1h Afterwards, it is transferred on grinder and grinds 4-5h, crosses 50 mesh sieves, you can obtain pre-mixing agent.
Beneficial effects of the present invention:Colloid MCC in pre-mixing agent of the present invention improves the stability of coating solution, reduces coating Liquid precipitate speed effect is better than by addition thickener to alleviate the coating solution rate of settling, and coating process is more smooth, coating Faster, unilateral effect is finer and smoother after coating for speed.Colloid MCC includes microcrystalline cellulose and sodium carboxymethylcellulose, and colloid MCC is Dispersant and protecting colloid are played a part of with main body, sodium carboxymethylcellulose with microcrystalline cellulose.
Embodiment
The present invention is carried out with reference to embodiment explanation is explained in detail.
A kind of new auxiliary material colloid MCC has been introduced to increase the stability of liquid, while again not in present invention premix agent prescription The unilateral effect after coating solution viscosity in use and coating can be influenceed.Colloid MCC is scattered in liquid phase, will not be in continuous phase It is middle to produce larger viscosity B coefficent, but play the role of hydrogen bond in solution stand, Weak Gels can be formed in continuous phase solution Space three-dimensional network structure.This network structure makes continuous solution increase its yield value, so that molecule equably divides It is dispersed in continuous phase, will not sinks.This structure can disappear or be destroyed again when being shaken or being shaken, and viscosity drops rapidly It is low, and recover the good mobility of its liquid.Colloid MCC is incorporated among the film-coated technique of the present invention, in high shear It can be uniformly dispersed under power (whipping process) effect, using its above-mentioned characteristic, ultimately form the colloidal solution of uniformity, strengthen liquid The yield value of phase, the sedimentation of insoluble particulate is prevented, this stable mechanism is different from original single increase viscosity, and it is stable Mechanism is network struture system, rather than high viscosity systems.
The determination process of formula:
1st, the present invention is carried out based on original high soverlay technique, so using colloid MCC stabilizers direct generation first For thickener of the prior art.Do not find there is incompatibility with other components in formula among whole ratio examination process Phenomenon occurs.
2nd, optimum proportioning examination
Based on different covering agent ratios in formula, different amounts of colloid MCC stabilizers are added from the rate of settling, Bao Zao Unilateral effect is coated to observe, try after process and coating, collects analysis of experimental data table, determines optimum proportioning.
Table 1 adds influences of the different amounts of colloid MCC to coating process
Analysis and summary:Increase with the ratio of insoluble covering agent particulate in film coating pre-mix dose, it is necessary to which colloid MCC is steady It is also different to determine agent adding proportion, by taking tested recipe as an example, it is 50% to add covering agent maximum ratio wherein, when colloid MCC is steady It is most preferable to determine effect when agent is added to 3%.Excessive addition colloid MCC stabilizers can cause liquid to tend to gel, it is necessary to more Big shearing force could destroy hydrogen bond structure, be unfavorable for bag and make.So colloid MCC stabilizers are used in film-coating premixing of the present invention Optimal proportion in agent prescription is 1-3%.
Embodiment 1
The red colour system stomach dissolution type pre-mixing agent of the present invention includes the component of following mass parts:
The preparation method of the red colour system stomach dissolved film coating pre-mix dose of the present invention comprises the following steps:
By the talcum powder of above-mentioned mass parts, HPMC, copolyvidone, polyvinyl alcohol, Macrogol 6000, glue Body MCC, purified water and ethanol (mass concentration 99%) uniformly mix 0.8h, and crystallite is fine in 35 DEG C of dry 5h, wherein colloid MCC The weight ratio of dimension element and sodium carboxymethylcellulose is 1:9, take intermediate to detect, moisture≤5% it is as qualified;It is qualified Afterwards, carmine lake, the titanium dioxide of above-mentioned mass parts are added, after mixing 0.5h, grinder grinding 5h is transferred to, crosses 50 mesh sieves, Detection, △ E≤2 are as qualified, need to be finely adjusted color during △ E > 2 until △ E≤2, produce pre-mixing agent.
Comparative example:
The component proportioning of red colour system film coating pre-mix dose comprising thickener:
The method for preparing the red colour system film coating pre-mix dose:
By the talcum powder of above-mentioned mass parts, HPMC, copolyvidone, polyvinyl alcohol, Macrogol 6000, hydroxyl Third methylcellulose E200, purified water and ethanol (mass concentration 99%) uniformly mix 0.8h, 35 DEG C of dry 5h, take intermediate Detection, content≤5% of moisture it is as qualified;After qualified, carmine lake, the titanium dioxide of above-mentioned mass parts are added, is mixed After 0.5h, grinder grinding 5h is transferred to, crosses 50 mesh sieves, detection, △ E≤2 are as qualified, need during △ E > 2 to carry out color Fine setting produces pre-mixing agent until △ E≤2.Obtained film coating pre-mix dose with the present invention pre-mixing agent compared with, compare It the results are shown in Table 2.
The comparative result of the pre-mixing agent of the present invention of table 2 and the pre-mixing agent performance of comparative example
Embodiment 2
The green of the present invention is the component that stomach dissolution type pre-mixing agent includes following mass parts:
The green of the present invention is that the preparation method of stomach dissolved film coating pre-mix dose comprises the following steps:
By the magnesium stearate of above-mentioned mass parts, HPMC, copolyvidone, polyvinyl alcohol, Liquid Macrogol, Colloid MCC, purified water and ethanol (mass concentration 99%) uniformly mix 1h, and crystallite is fine in 40 DEG C of dry 5h, wherein colloid MCC The weight ratio of dimension element and sodium carboxymethylcellulose is 1.2:8.8, take intermediate to detect, content≤5% of moisture it is as qualified; After qualified, light green color lake, the titanium dioxide of above-mentioned mass parts are added, after mixing 0.8h, grinder grinding 4h is transferred to, crosses 50 mesh Sieve, detection, △ E≤2 are as qualified, need to be finely adjusted color during △ E > 2 until △ E≤2, produce pre-mixing agent.
Comparative example:
Green comprising thickener is that the component of film coating pre-mix dose is:
The method that the green is film coating pre-mix dose is prepared to comprise the following steps:
By the magnesium stearate of above-mentioned mass parts, HPMC, copolyvidone, polyvinyl alcohol, Liquid Macrogol, HPMC E200, purified water and ethanol (mass concentration 99%) uniformly mix 1h, 40 DEG C of dry 5h, take intermediate Detection, content≤5% of moisture it is as qualified;After qualified, light green color lake, the titanium dioxide of above-mentioned mass parts are added, is mixed After 0.8h, grinder grinding 4h is transferred to, crosses 50 mesh sieves, detection, △ E≤2 are as qualified, need during △ E > 2 to carry out color Fine setting produces pre-mixing agent until △ E≤2.Obtained film coating pre-mix dose with the present invention pre-mixing agent compared with, compare It the results are shown in Table 3.
The comparative result of the pre-mixing agent of the present invention of table 3 and the pre-mixing agent performance of comparative example
Embodiment 3
The yellow class stomach dissolution type pre-mixing agent of the present invention includes the component of following mass parts:
The green of the present invention is that the preparation method of stomach dissolved film coating pre-mix dose comprises the following steps:
By the stearic acid of above-mentioned mass parts, HPMC, copolyvidone, polyvinyl alcohol, glyceryl triacetate, glue Body MCC, purified water and ethanol (mass concentration 99%) uniformly mix 1h, microcrystalline cellulose in 45 DEG C of dry 5h, wherein colloid MCC The weight ratio of element and sodium carboxymethylcellulose is 1.5:8.5, take intermediate to detect, content≤5% of moisture it is as qualified;Close After lattice, lemon yellow color lake, the titanium dioxide of above-mentioned mass parts are added, after mixing 1h, grinder grinding 5h is transferred to, crosses 50 mesh sieves, Detection, △ E≤2 are as qualified, need to be finely adjusted color during △ E > 2 until △ E≤2, produce pre-mixing agent.
Comparative example:
The component of yellow class film coating pre-mix dose comprising thickener is:
The method that the green is film coating pre-mix dose is prepared to comprise the following steps:
By the stearic acid of above-mentioned mass parts, HPMC, copolyvidone, polyvinyl alcohol, glyceryl triacetate, hydroxyl Third methylcellulose E200, purified water and ethanol (mass concentration 99%) uniformly mix 1h, 45 DEG C of dry 5h, take middle physical examination Survey, moisture≤5% it is as qualified;After qualified, lemon yellow color lake, the titanium dioxide of above-mentioned mass parts are added, after mixing 1h, Grinder grinding 5h is transferred to, crosses 50 mesh sieves, detection, △ E≤2 are as qualified, need to be finely adjusted color directly during △ E > 2 To △ E≤2, pre-mixing agent is produced.Obtained film coating pre-mix dose with the present invention pre-mixing agent compared with, comparative result is shown in Table 4.
The comparative result of the pre-mixing agent of the present invention of table 4 and the pre-mixing agent performance of comparative example
To sum up, substitute thickener of the prior art with colloid MCC stabilizers, film coating pre-mix dose dry powder with after coating Tablet passes through accelerated test stability test, as a result finds no the phenomenon for influenceing film coating pre-mix dose performance, confirms Colloid MCC stabilizers can solve the technical problem that high covering type film coating pre-mix dose easily precipitates in the prior art.
Presently preferred embodiments of the present invention, it is not intended to limit the invention, it is all to be made in substantive content of the present invention Any modification, equivalent substitution and simple modifications etc., should be included in the scope of the protection.

Claims (6)

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 mass parts:Into membrane material Expect 30-50 parts, antiplastering aid 10-20 parts, colouring agent 0.5-5 parts, covering agent 20-30 parts, plasticizer 5-15 parts, colloid MCC 1-3 Part;
Wherein, colloid MCC includes the matter of microcrystalline cellulose and sodium carboxymethylcellulose, microcrystalline cellulose and sodium carboxymethylcellulose It is 1-1.5 to measure ratio:8.5-9.
2. stomach dissolved film coating pre-mix dose according to claim 1, it is characterised in that filmogen includes following quality The component of part:HPMC 1-5 parts, polyvinyl alcohol 1-3 parts, copolyvidone 1-2 parts.
3. stomach dissolved film coating pre-mix dose according to claim 1, it is characterised in that antiplastering aid is talcum powder, tristearin Any one in sour magnesium, stearic acid.
4. stomach dissolved film coating pre-mix dose according to claim 1, it is characterised in that covering agent is titanium dioxide.
5. stomach dissolved film coating pre-mix dose according to claim 1, it is characterised in that plasticizer is polyethylene glycol 6000th, Liquid Macrogol, polyethylene glycol 400, propyl alcohol, glycerine, glyceryl triacetate, dicarboxylic acid dimethyl ester, triacetyl glycerine In any one.
A kind of 6. method for preparing the stomach dissolved film coating pre-mix dose described in claim any one of 1-5, it is characterised in that should Method comprises the following steps:
(1) filmogen 30-50 parts, antiplastering aid 10-20 parts, plasticizer 5-15 parts, colloid MCC1-3 parts are taken, with purified water 6-12 Part, ethanol 2-4 parts uniformly mix 0.8-1h, 35-45 DEG C of dry 4-5h;
(2) colouring agent 0.5-5 parts, covering agent 20-30 parts are added in the dried mixture of upper step, after mixing 0.5-1h, is turned Move to and 4-5h is ground on grinder, cross 50 mesh sieves, you can obtain pre-mixing agent.
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CN106075461A (en) * 2016-07-11 2016-11-09 成都中牧生物药业有限公司 A kind of film coating pre-mix dose hiding abnormal flavour and preparation method
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
CN108785267B (en) * 2018-08-14 2020-05-19 北京百奥药业有限责任公司 Valsartan amlodipine tablet and preparation method thereof
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
CN110559270B (en) * 2019-09-17 2020-06-23 扬子江药业集团广州海瑞药业有限公司 Sitagliptin phosphate pharmaceutical composition and preparation method thereof

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CN102512401A (en) * 2012-01-16 2012-06-27 北京英茂药业有限公司 Water-soluble film coated premix agent

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