CN103341173A - Stomach-soluble film coating premixing agent and preparation method thereof - Google Patents
Stomach-soluble film coating premixing agent and preparation method thereof Download PDFInfo
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- CN103341173A CN103341173A CN2013102498360A CN201310249836A CN103341173A CN 103341173 A CN103341173 A CN 103341173A CN 2013102498360 A CN2013102498360 A CN 2013102498360A CN 201310249836 A CN201310249836 A CN 201310249836A CN 103341173 A CN103341173 A CN 103341173A
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Abstract
The invention discloses a stomach-soluble film coating premixing agent which comprises the following components in parts by mass: 10-40 parts of hydroxypropyl cellulose or hydroxypropyl methyl cellulose or mixture of the two, 20-30 parts of acrylic resin, 5-10 parts of talcum powder, 10-20 parts of glycerol triacetate and 5-10 parts of ethanol with mass concentration of 99%. The preparation method comprises the following steps of: (1) uniformly mixing the components in the formula at 18-30 DEG C and stirring for one hour; (2) drying the mixture obtained by the step (1) at 35-45 DEG C and drying for five hours; and (3) grinding the mixture dried in the step (2) for five hours, sieving with a 50-mesh sieve, and uniformly mixing for 60 minutes. The stomach-soluble film coating premixing agent and the preparation method thereof disclosed by the invention have the advantages that the prepared coating can be well dissolved in gastric juice with a pH value of 0.9-1.8, and a good moisture-proof effect is realized.
Description
Technical field
The present invention relates to drug coating and make prescription and Technology field, specifically is a kind of stomach dissolved film coating pre-mix dose and preparation method thereof.
Background technology
The drug coating technology is ancient and the most the most frequently used a kind of method during preparation is produced, and however, it is believed that for a long time coating is a kind of Technology, rather than science.Nineteen thirty has been invented film-coated technique, and after being applied to pharmaceuticals industry the 1950's, people have had new understanding to coating, development along with polymer science, macromolecular material with various performances constantly is introduced into this field, and film-coated technique progressively maturation is applied in the preparation production.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 begin to introduce this technology, in the last few years, along with film-coated technique developing rapidly in China's preparation production, some with the professional technique company that applies this technology and develop to manage relevant coating material in succession, for positive impetus has been played in the extensive use of film-coated technique in preparation industry.
In the contemporary society that the pharmaceutical preparation technology develops rapidly, the coating of medicine has progressively been realized by sugar-coat to film-coated transformation, the exploitation of stomach dissolved film coating pre-mix dose and application are important development courses of film-coated technique, also solved simultaneously and only relied on label technology, the deficiency that prescription adjustment is difficult to produce a desired effect, be that cellulose derivative is as filmogen mostly in the present stomach dissolved film coating pre-mix dose, when running into the medicine that some high moisture absorptions and extractum overflows, this class clothing film is just slightly inadequate, at this moment we just need exploitation one class can at and the novel thin film coating pre-mixing agent that addresses these problems.
Summary of the invention
For solving the problem of the easy moisture absorption of above-mentioned existing stomach dissolution type drug coating; the present invention has developed a kind of novel gastric solubleness film coating pre-mix dose, makes the penetrating rate of steam of clothing film obtain very big improvement, thus the protection label; reach moistureproof purpose, also can make label, label color more stable.
The technical scheme that realizes above-mentioned purpose is, a kind of stomach dissolved film coating pre-mix dose that the present invention develops, this pre-mixing agent comprises that 10～40 parts hydroxypropyl cellulose or hydroxypropyl emthylcellulose or both mix, 20～30 parts of acrylic resins, 5～10 parts Pulvis Talci, 10～20 parts of triacetyl glycerines, mass concentrations are 5～10 parts of 99% ethanol, and above-mentioned umber is each composition at the mass fraction of pre-mixing agent.
Adopt the acrylic resin of certain mass umber to replace a part of hydroxypropyl cellulose or hydroxypropyl emthylcellulose in the prescription, after being added into acrylic resin, the penetrating rate of the steam of clothing film has obtained very big improvement, simultaneously also can well dissolving in gastric juice pH 0.9-1.8.
Pre-mixing agent of the present invention also can form shades of colour, and it is 5～10 parts titanium dioxide that white the time adds mass fraction, when forming shades of colour, can add mass fraction and be 1～5 part pigment.
The present invention is except disclosing the prescription of pre-mixing agent, the preparation method of pre-mixing agent is also disclosed, this method comprises the steps, (1) with following composition, 10～40 parts hydroxypropyl cellulose or hydroxypropyl emthylcellulose or both mix, 20～30 parts of acrylic resins, 5～10 parts Pulvis Talci, 10～20 parts of triacetyl glycerines, mass concentrations are 5～10 parts of 99% ethanol, evenly mix under 18～30 ℃ of conditions and stirring 1h, what above-mentioned umber all represented is the mass fraction of each composition in the coating pre-mixing agent; Generally the time all can in composition, add suitable quantity of water in operation, make that mixed material is moistening to get final product;
(2) mixture that will go up the step can detect the test of moisture content to mixture once at 35～45 ℃ of dry 5h down after this step drying, o'clock is qualified with moisture≤8% generally.
(3) dried mixture of (2) step is ground 5h, after 50 mesh sieves, evenly mixed 60 minutes the back of sieving, and can obtain pre-mixing agent.
The film coating pre-mix dose of the present invention's preparation can also add shades of colour, adds various pigment and get final product in composition, as green, yellow, redness, blueness, purple etc.In the described step (3) when pre-mixing agent comprises titanium dioxide, pigment, the operational approach of step (3) is, to the mixture after grinding, cross 50 mesh sieves, sieve the titanium dioxide of back adding 5～10 weight portions, the even mixing 60 minutes of pigment of 1～5 weight portion, sampling (color is carried out) detects, and △≤3 o'clock judgement product is qualified, △＞3 o'clock need are finely tuned color or are prolonged incorporation time until △≤3, and (△ is value of chromatism) can obtain coloured pre-mixing agent.
Beneficial effect of the present invention: adopt the acrylic resin of certain mass umber to replace a part of hydroxypropyl cellulose or hydroxypropyl methylcellulose in the prescription, after being added into acrylic resin, the penetrating rate of the steam of clothing film has obtained very big improvement, can play simultaneously moisture content makes the label moisture absorption through the clothing film the effect that intercepts, also can in gastric juice, well dissolve, and this process using physical method, the change of character can not take place in individual material in process of production, the production method simple controllable, the positive impetus that the development of pharmaceutical preparation is played.
Description of drawings
Fig. 1 is the coating of embodiment one and the dissolving-time plot of existing coating;
Fig. 2 is coating and the existing coating hydroscopicity correlation curve figure of embodiment two.
Among the figure, the gastric solubleness solubility curve of curve 1, existing coating; Curve 2, the embodiment of the invention one coating gastric solubleness solubility curve; The hydroscopicity curve of curve 3, existing prescription coating; Curve 4, the embodiment of the invention two coating hydroscopicity curves.
The specific embodiment
Further specify content of the present invention below in conjunction with specific embodiment.
Embodiment one: a kind of stomach dissolved film coating pre-mix dose that the present invention develops, its prescription comprises that 10 parts of hydroxypropyl celluloses, 20 parts of acrylic resins, 5 parts of Pulvis Talci, 10 parts of triacetyl glycerines, mass concentrations are 5 parts of 99% ethanol, and above-mentioned umber is each composition at the mass fraction of pre-mixing agent.
The preparation method of the coating pre-mixing agent of this new composition of the present invention comprises the steps, (1) be that 99% ethanol evenly mixes and stir 1h for 5 parts with 10 parts of hydroxypropyl celluloses, 20 parts of acrylic resins, 5 parts of Pulvis Talci, 10 parts of triacetyl glycerines, mass concentrations under 18～30 ℃ of conditions, the method of routine is to see whether to keep moistening after the various compositions mixing when operation, also can in mixture, add little water in order to keep moistening, to moistening getting final product, what above-mentioned umber all represented is the mass fraction of each composition in the coating pre-mixing agent with the hands touch perception;
(2) mixture that will go up the step is at 35～45 ℃ down behind the dry 5h, and sampling detects, and detects moisture and must not cross 8%, enters down the step after qualified;
(3) dried mixture of (2) step is ground 5h, cross 50 mesh sieves, evenly mixed 60 minutes the back of sieving, and can obtain pre-mixing agent.
Illustrate by experiment that below the coating that pre-mixing agent of the present invention makes is better than existing stomach dissolution type coating dissolubility: the coating that utilizes the composition among the embodiment one to make, do the solubility test of gastric solubleness with stomach dissolution type coating in the prior art, the composition of gastric solubleness coating is that 25 parts of hydroxypropyl celluloses, 1 part of Pulvis Talci, 5 parts of triacetyl glycerines, mass concentrations are 5 parts of 99% ethanol in the prior art, above-mentioned is mass fraction, and the result as shown in Figure 1.
Embodiment two: a kind of stomach dissolved film coating pre-mix dose that the present invention develops, its prescription comprises that 20 parts of hydroxypropyl celluloses, 20 parts of hydroxypropyl emthylcelluloses, 30 parts of acrylic resins, 10 parts of Pulvis Talci, 20 parts of triacetyl glycerines, mass concentrations are 10 parts of 99% ethanol, and above-mentioned umber is each composition at the mass fraction of pre-mixing agent.
The preparation method of the coating pre-mixing agent of this new composition of the present invention is with embodiment one.
The coating of application present embodiment and existing composition coating are done accelerated test and are tested both hydroscopicities, Pulvis Talci, hydroxypropyl emthylcellulose 60 weight portions, the triacetyl glycerine of 10 weight portions, mass concentration that existing stomach dissolution type coating composition is 5 weight portions are 99% ethanol, 10 weight portions, test result as shown in Figure 2, Fig. 2 represents hydroscopicity and the curve of time in the accelerated test, the hydroscopicity curve of the existing coating of curve 3 representatives, curve 4 represents the embodiment of the invention two coating hydroscopicity curves.
Embodiment three: a kind of stomach dissolved film coating pre-mix dose that the present invention develops, its prescription comprises that 10 parts of hydroxypropyl emthylcelluloses, 25 parts of acrylic resins, 7 parts of Pulvis Talci, 15 parts of triacetyl glycerines, mass concentrations are the titanium dioxide of 7 parts, 5 parts of 99% ethanol, 1 part pigment, and above-mentioned umber is each composition at the mass fraction of pre-mixing agent.
The coating pre-mixing agent can have multiple color, as Bluepoint, green, purple, redness, white, yellow, crocus, white, its preparation method is, (1) with 10 parts of hydroxypropyl emthylcelluloses, 25 parts of acrylic resins, 7 parts of Pulvis Talci, 12 parts of triacetyl glycerines, mass concentrations is 6 parts of 99% ethanol, evenly mix under 18～30 ℃ of conditions and stirring 1h, what above-mentioned umber all represented is the mass fraction of each composition in the coating pre-mixing agent;
(2) mixture that will go up the step is at 35～45 ℃ down behind the dry 5h, and sampling detects, and detects moisture and must not cross 8%, enters down the step after qualified;
(3) dried mixture of (2) step is ground, grind 5h, mixture after the grinding, cross 50 mesh sieves, add 5 parts titanium dioxide then, 1 part the pigment of required color evenly mixed 60 minutes, sampling (color is carried out) detects, and △≤3 o'clock judgement product is qualified, and △＞3 o'clock need are finely tuned color or prolonged incorporation time until △≤3.Can obtain coloured pre-mixing agent.
Embodiment four: a kind of stomach dissolved film coating pre-mix dose that the present invention develops, its prescription comprises that 40 parts of hydroxypropyl celluloses, 26 parts of acrylic resins, 8 parts of Pulvis Talci, 18 parts of triacetyl glycerines, mass concentrations are the titanium dioxide of 9 parts, 7 parts of 99% ethanol, 3 parts pigment, above-mentioned umber is each composition at the mass fraction of pre-mixing agent, and its method that forms versicolor pre-mixing agent is with embodiment three.
Embodiment five: a kind of stomach dissolved film coating pre-mix dose that the present invention develops, its prescription comprises that 40 parts of hydroxypropyl emthylcelluloses, 26 parts of acrylic resins, 8 parts of Pulvis Talci, 18 parts of triacetyl glycerines, mass concentrations are the titanium dioxide of 9 parts, 7 parts of 99% ethanol, 3 parts pigment, above-mentioned umber is each composition at the mass fraction of pre-mixing agent, and its method that forms versicolor pre-mixing agent is with embodiment three.
Technique scheme is only for terse explanation content of the present invention, those skilled in the art its prescription is made some do not have change on the essential meaning, all should belong within protection scope of the present invention.
Claims (5)
1. stomach dissolved film coating pre-mix dose, it is characterized in that, this pre-mixing agent comprises that 10～40 parts hydroxypropyl cellulose or hydroxypropyl emthylcellulose or both mix, 20～30 parts of acrylic resins, 5～10 parts Pulvis Talci, 10～20 parts of triacetyl glycerines, mass concentrations are 5～10 parts of 99% ethanol, and above-mentioned umber is each composition at the mass fraction of pre-mixing agent.
2. stomach dissolved film coating pre-mix dose according to claim 1 is characterized in that, this pre-mixing agent comprises that also mass fraction is 5～10 parts titanium dioxide.
3. stomach dissolved film coating pre-mix dose according to claim 2 is characterized in that, this pre-mixing agent comprises that also mass fraction is 1～5 part pigment.
4. method for preparing the described coating pre-mixing agent of claim 1, it is characterized in that, this method comprises the steps, (1) with following composition, 10～40 parts hydroxypropyl cellulose or hydroxypropyl emthylcellulose or both mix, 20～30 parts of acrylic resins, 5～10 parts Pulvis Talci, 10～20 parts of triacetyl glycerines, mass concentrations are 5～10 parts of 99% ethanol, evenly mix under 18～30 ℃ of conditions and stirring 1h, what above-mentioned umber all represented is the mass fraction of each composition in the coating pre-mixing agent;
(2) will go up the mixture in step at 35～45 ℃ of following dry 5h;
(3) dried mixture of (2) step is ground 5h, after 50 mesh sieves, evenly mixed 60 minutes the back of sieving, and can obtain pre-mixing agent.
5. the method for preparing the coating pre-mixing agent according to claim 4, it is characterized in that, in the described step (3) when pre-mixing agent comprises titanium dioxide, pigment, the operational approach of step (3) is, to the mixture after (3) grinding, cross 50 mesh sieves, the back of sieving adds the titanium dioxide of 5～10 weight portions, the pigment of 1～5 weight portion evenly mixed 60 minutes, can obtain pre-mixing agent.
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| CN2013102498360A CN103341173A (en) | 2013-06-21 | 2013-06-21 | Stomach-soluble film coating premixing agent and preparation method thereof |
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| CN2013102498360A CN103341173A (en) | 2013-06-21 | 2013-06-21 | Stomach-soluble film coating premixing agent and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104958272A (en) * | 2015-08-03 | 2015-10-07 | 北京英茂药业有限公司 | Gastric-soluble film coating premixed agent and preparation method thereof |
| CN105999286A (en) * | 2016-07-11 | 2016-10-12 | 成都中牧生物药业有限公司 | Dampproof film coating premix and preparation method |
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| CN1244393A (en) * | 1998-08-11 | 2000-02-16 | 苏乐群 | Gastritis treating tablet |
| CN1628856A (en) * | 2004-09-09 | 2005-06-22 | 成都市泰山薄膜包衣有限公司 | Film coated premix dissoluble in stomach and its preparation method |
| CN101380475A (en) * | 2008-10-22 | 2009-03-11 | 北京英茂药业有限公司 | Preparation method of film coating pre-mixing agent and uses thereof |
| CN102327245A (en) * | 2011-07-26 | 2012-01-25 | 连云港康力特药业有限公司 | High-performance film coating premix capable of covering peculiar smell, and preparation method thereof |
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2013
- 2013-06-21 CN CN2013102498360A patent/CN103341173A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1244393A (en) * | 1998-08-11 | 2000-02-16 | 苏乐群 | Gastritis treating tablet |
| CN1628856A (en) * | 2004-09-09 | 2005-06-22 | 成都市泰山薄膜包衣有限公司 | Film coated premix dissoluble in stomach and its preparation method |
| CN101380475A (en) * | 2008-10-22 | 2009-03-11 | 北京英茂药业有限公司 | Preparation method of film coating pre-mixing agent and uses thereof |
| CN102327245A (en) * | 2011-07-26 | 2012-01-25 | 连云港康力特药业有限公司 | High-performance film coating premix capable of covering peculiar smell, and preparation method thereof |
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| 李欣: "薄膜包衣预混剂的应用", 《化工科技市场》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104958272A (en) * | 2015-08-03 | 2015-10-07 | 北京英茂药业有限公司 | Gastric-soluble film coating premixed agent and preparation method thereof |
| CN104958272B (en) * | 2015-08-03 | 2018-04-27 | 北京英茂药业有限公司 | A kind of stomach dissolved film coating pre-mix dose and preparation method thereof |
| CN105999286A (en) * | 2016-07-11 | 2016-10-12 | 成都中牧生物药业有限公司 | Dampproof film coating premix and preparation method |
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Application publication date: 20131009 |