CN104587481A - Preparation method of moisture-proof traditional Chinese medicine coated film - Google Patents
Preparation method of moisture-proof traditional Chinese medicine coated film Download PDFInfo
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- CN104587481A CN104587481A CN201310530262.4A CN201310530262A CN104587481A CN 104587481 A CN104587481 A CN 104587481A CN 201310530262 A CN201310530262 A CN 201310530262A CN 104587481 A CN104587481 A CN 104587481A
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Abstract
The invention discloses a preparation method of a moisture-proof traditional Chinese medicine coated film, which relates to a coating technology of the traditional Chinese medicine and belongs to the medicinal preparation field. The moisture-proof traditional Chinese medicine coated film comprises the following components: 30-40 parts of hydroxypropyl methyl cellulose, 5-8 parts of triethyl citrate, 6-10 parts of xylitol, 4-8 parts of castor oil, 4-8 parts of tween-80, 14-18 parts of dextrin, 6-10 parts of aerosol, 6-10 parts of zein, 5-10 parts of 1% of artificial food coloring solution, 350-420 parts of distilled water (40-50 DEG C) and balance of ethanol with 95% of concentration; wherein weight unit of solid is gram, and volume unit of liquid is milliliter. The moisture-proof traditional Chinese medicine coated film has the beneficial effect of stable chemical property of a film forming substance, inertia to an enzyme system, no physiological toxicity and no usage of cane sugar; the coated film has the advantages of moisture resistance, heat resistance, cold resistance and abrasion resistance which are better than that of the sugar coated tablets, so that the stability of the coated film is increased, and storage period is prolonged.
Description
Technical field
The present invention relates to a kind of Chinese medicine art for coating, belong to pharmaceutical preparation neck, specifically a kind of moistureproof Chinese medicine film coating preparation method.
Background technology
Complex chemical composition contained by Chinese medicine, be no matter bioactive ingredients as alkaloids, glycoside, volatile oil, aminoacid etc., or abiotic active ingredient is as saccharide, protein, pigment, resin, inorganic salt etc., mostly has very strong hygroscopicity.Wet, volatile, maybe to cause taste, olfactory sensation discomfort composition is drawn by force in plant, so be generally all surrounded by sugarcoating layer to play the effect of mass exchange inside and outside certain isolated tablet in the past owing to including.Some patient is not suitable for taking too many sugar-coat, also the easy moisture absorption of coated tablet, go mouldy, variable color etc.The art for coating length consuming time of sugarcoating layer, to expend the energy many, dust from flying, and environmental pollution is serious, and people's force intensity is large and how to operate by rule of thumb, affect the healthy of tablet quality and workman.The primary raw material of coated tablet is simple syrup and Pulvis Talci, and sugarcoating layer itself is unstable, and moisture resistance, heat resistanceheat resistant, cold tolerance are poor, easy to change, stores improper easily to fission.In addition, in coated tablet, amount of talc accounts for 35% of label weight, and micropowder silica gel is cold in nature, and containing micro-asbestos etc., clothes for patients causes potential eutrophication to health after using.Dust is large, so replace sugar-coat mainly with film-coat now.
Moisture absorption mainly refers to that material is exposed in high humidity environment, and a small amount of moisture in air is in conjunction with its surface and overcome resistance to mass tranfer and enter medicine inside, physical bond occurs until the process that balances with the wet position of having in vain in preparation.The moisture absorption degree of medicine and speed depend primarily on the chemical constitution of medicine and the humidity of environment, normal containing hydrophilic group in these structures, when the polar hydroxyl groups of drug molecule and water in air molecule forms hydrogen bond or produces other molecular separating force, just present hygroscopic effect.After medicine moisture absorption, not only outward appearance changes, color burn, deliquescing, caking, even cause composition to change, stability, safety and treatment curative effect all can by impacts to a certain extent, and therefore the sucting wet problem of Chinese medicine preparation is the problem needing overriding concern in pharmaceutical manufacturing always.
Development along with macromolecular material and the application at pharmaceutical field thereof, film-coated technique is progressively applied in field of pharmaceutical preparations, and it is moistureproof, taste masking performance is better; Automatization, standardization level are high, and sheet heavily increases few (only need increase by 2 ~ 4%), consuming time few; Film-coated technique experienced by the evolution from organic solvent coating to water system coating.Film coating is that macromolecular compound is sprayed on thing wicking surface equably by spray method under suitable solvent and temperature and processing conditions, forms the plastic macromolecule material film layers of number micron thickness.Film-coated technique is widely used in solid and the semi-solid preparations such as tablet, granule, pill, extractum, drug powder, capsule, except have Coating times short, increase weight little, toxicity is little, can reach except sustained-release and controlled release requirement, also have good moisture effect, therefore film-coated technique has good prospect for the protection against the tide of Chinese medicine preparation.
Summary of the invention
The object of the present invention is to provide a kind of moistureproof Chinese medicine film coating preparation method, solve the defect existing for traditional sugar-coat technique, a kind of strong film art for coating is provided, save time, material-saving, power saving, saving of labor, and the moisture resistance of tablet, heat resistanceheat resistant, cold tolerance can be improved, reduce the side effect of tablet.
For achieving the above object, the moistureproof Chinese medicine film coating of one of the present invention, is characterized in that: its formula following (parts by weight unit): hydroxypropyl methylcellulose 30 ~ 40 parts, triethyl citrate 5 ~ 8 parts, xylitol 6 ~ 10 parts, Oleum Ricini 4 ~ 8 parts, tween 80 4 ~ 8 parts, 14 ~ 18 parts, dextrin, micropowder silica gel 6 ~ 10 parts, zein 6 ~ 10 parts, 1% edible pigment solution 5 ~ 10 parts, distilled water (40 ~ 50 DEG C) 350 ~ 420 parts, 95% ethanol add to 1000 parts; Wherein said solid is in unit of weight gram, and liquid is in volume unit milliliter.
One of the present invention moistureproof Chinese medicine film coating preparation method, is characterized in that:
One, hydroxypropyl methylcellulose and for subsequent use with dissolve with ethanol triethyl citrate is dissolved with the distilled water of 40 ~ 50 DEG C respectively; Oleum Ricini is added and tween 80 is for subsequent use in triethyl citrate ethanol;
Two, after liquid mixing described in step one is even, added the dextrin of 80 mesh sieves, micropowder silica gel and zein successively, then added edible pigment solution, stirred, for subsequent use after colloid mill grinds 4 ~ 5 times;
Three, screen out the fine powder in tablet, fragment and chip, tablet is placed in coating pan and is preheated to 45 ~ 55 DEG C, to tablet spraying coating material, after Swertia Tablet surface coverage one deck coating material, stop hydrojet, with hot blast drying;
Four, control at 40 ~ 50 DEG C by tablet temperature, by per kilogram label, the ratio of spray coating solution 400 ± 50ml is to its batch (-type) spraying coating material, and constantly detect the wettability of coat tablets, prevent the mutual adhesion of tablet, spray one deck, dry one deck, until coating material has sprayed;
Five, after last one deck coating material drying, continue to open coating pan, change and blow a cold wind over, till surface-brightening, take out the tablet after coating, dry under being placed in the temperature of less than 40 DEG C, obtained finished product.
One of the present invention moistureproof Chinese medicine film coating preparation method, its beneficial effect is: film forming matter stable chemical nature, to enzyme system in falling property, without physiological-toxicity; The art for coating operation cycle short (being only 1/5 of sugar-coat processing operation time), save time, material-saving, power saving, saving of labor, and clothing layer fast drying, medicine is influenced by heat few, is conducive to improving drug quality; After coating, sheet heavily increases seldom, can keep former shape, not use sucrose; The moisture resistance of this film-coat, heat resistanceheat resistant, cold-resistant and abrasion resistance properties are all better than coated tablet, improve the stability of tablet, extend storage period.
Detailed description of the invention
Following examples are that the present invention goes out to set forth further.
Embodiment 1
1. get hydroxypropyl methylcellulose 32g, triethyl citrate 6g, xylitol 8g, Oleum Ricini 7ml, tween 80 5ml, dextrin 14g, micropowder silica gel 6g, zein 10g, the edible pigment solution 8ml of 1%, the distilled water 360ml of 42 ± 1 DEG C, the ethanol of 95% adds to 1000ml.
2. manufacturing process (consumption is as 1):
1. use the distilled water of 42 ± 1 DEG C to dissolve hydroxypropyl methylcellulose and for subsequent use with dissolve with ethanol triethyl citrate respectively, in triethyl citrate ethanol, add Oleum Ricini and tween 80 is for subsequent use;
2. by liquid mixing described in step one evenly after, added the dextrin of 80 mesh sieves, micropowder silica gel and zein successively, then added edible pigment solution, stirred, for subsequent use after colloid mill 5 times;
3. screen out the fine powder in tablet, fragment and chip, tablet is placed in coating pan and is preheated to 48 ± 2 DEG C, to tablet spraying coating material, after Swertia Tablet surface coverage one deck coating material, stop hydrojet, with hot blast drying;
4. tablet temperature is controlled at 42 ± 1 DEG C, with the ratio of per kilogram label spray coating solution 400ml to its batch (-type) spraying coating material, and constantly detect the wettability of coat tablets, prevent the mutual adhesion of tablet, spray one deck, dry one deck, till coating material has sprayed,
5. after last one deck coating material drying, continue to open coating pan, change and blow a cold wind over, till surface-brightening, take out the tablet after coating, dry under being placed in room temperature.
Embodiment 2
1. film-coated formula is: hydroxypropyl methylcellulose 38g, triethyl citrate 7g, xylitol 6g, Oleum Ricini 5ml, tween 80 7ml, dextrin 17g, micropowder silica gel 8g, zein 7g, edible pigment solution 6ml, distilled water (47 ± l DEG C) 400ml of 1%, the ethanol of 95% add to 1000ml.
2. enrobing processes is identical with embodiment 1.
Embodiment 3
1. film-coated formula is: hydroxypropyl methylcellulose 38g, triethyl citrate 7g, xylitol 6g, Oleum Ricini 5ml, tween 80 7ml, dextrin 17g, micropowder silica gel 8g, zein 7g, edible pigment solution 6ml, distilled water (47 ± l DEG C) 400ml of 1%, the ethanol of 95% add to 1000ml.
2. enrobing processes is identical with embodiment 1.
The tablet for treating common cold agent that present invention process is obtained and the tablet for treating common cold agent sampling inspection obtained by sugar-coat technique, appearance results is as follows:
Coated tablet: surface is not whole, uniform color, bright-coloured light.
Film coated tablets: profile is complete, clothing layer is firm, and thickness is consistent, uniform color, and fineness is better, but the slightly dim too late coated tablet of color and luster becomes clear.Coated tablet under infrared ray directly shines, there will be when 70 ~ 80 DEG C ,-5 DEG C fade, cruelly split, dissolve, disintegration time > 60min.
Claims (2)
1. a moistureproof Chinese medicine film coating, is characterized in that: its formula is as follows: hydroxypropyl methylcellulose 30 ~ 40 parts, triethyl citrate 5 ~ 8 parts, xylitol 6 ~ 10 parts, Oleum Ricini 4 ~ 8 parts, tween 80 4 ~ 8 parts, 14 ~ 18 parts, dextrin, micropowder silica gel 6 ~ 10 parts, zein 6 ~ 10 parts, 1% edible pigment solution 5 ~ 10 parts, distilled water (40 ~ 50 DEG C) 350 ~ 420 parts, 95% ethanol add to 1000 parts; Wherein said solid is in unit of weight gram, and liquid is in volume unit milliliter.
2. a moistureproof Chinese medicine film coating preparation method, is characterized in that:
1. hydroxypropyl methylcellulose and for subsequent use with dissolve with ethanol triethyl citrate is dissolved with the distilled water of 40 ~ 50 DEG C respectively; Oleum Ricini is added and tween 80 is for subsequent use in triethyl citrate ethanol;
2. by liquid mixing described in step one evenly after, added the dextrin of 80 mesh sieves, micropowder silica gel and zein successively, then added edible pigment solution, stirred, for subsequent use after colloid mill mill 4 ~ 5 times;
3. screen out the fine powder in tablet, fragment and chip, tablet is placed in coating pan and is preheated to 45 ~ 55 DEG C, to tablet spraying coating material, after Swertia Tablet surface coverage one deck coating material, stop hydrojet, with hot blast drying;
4. control at 40 ~ 50 DEG C by tablet temperature, by per kilogram label, the ratio of spray coating solution 400 ± 50ml is to its batch (-type) spraying coating material, and constantly detect the wettability of coat tablets, prevent the mutual adhesion of tablet, spray one deck, dry one deck, until coating material has sprayed;
5. after last one deck coating material drying, continue to open coating pan, change and blow a cold wind over, till surface-brightening, take out the tablet after coating, dry under being placed in the temperature of less than 40 DEG C, obtained finished product.
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| CN201310530262.4A CN104587481A (en) | 2013-10-31 | 2013-10-31 | Preparation method of moisture-proof traditional Chinese medicine coated film |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104971354A (en) * | 2015-05-15 | 2015-10-14 | 广东一力罗定制药有限公司 | Film coating and preparation method thereof |
| CN107242973A (en) * | 2017-05-15 | 2017-10-13 | 陈歆 | A kind of children's tablet package that can be bright |
| CN107550883A (en) * | 2017-10-10 | 2018-01-09 | 常州市天宁区鑫发织造有限公司 | A kind of preparation method of damp-proof Chinese medicine sugar-coat |
| CN117462507A (en) * | 2023-12-28 | 2024-01-30 | 山东齐都药业有限公司 | Vonola fumarate crude drug composition and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104971354A (en) * | 2015-05-15 | 2015-10-14 | 广东一力罗定制药有限公司 | Film coating and preparation method thereof |
| CN104971354B (en) * | 2015-05-15 | 2016-02-24 | 广东一力罗定制药有限公司 | A kind of film coating and preparation method thereof |
| CN107242973A (en) * | 2017-05-15 | 2017-10-13 | 陈歆 | A kind of children's tablet package that can be bright |
| CN107550883A (en) * | 2017-10-10 | 2018-01-09 | 常州市天宁区鑫发织造有限公司 | A kind of preparation method of damp-proof Chinese medicine sugar-coat |
| CN117462507A (en) * | 2023-12-28 | 2024-01-30 | 山东齐都药业有限公司 | Vonola fumarate crude drug composition and preparation method thereof |
| CN117462507B (en) * | 2023-12-28 | 2024-03-15 | 山东齐都药业有限公司 | Vonola fumarate crude drug composition and preparation method thereof |
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Application publication date: 20150506 |
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