CN106138003A - A kind of stable type film coating pre-mix dose and preparation method - Google Patents
A kind of stable type film coating pre-mix dose and preparation method Download PDFInfo
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- CN106138003A CN106138003A CN201610540918.4A CN201610540918A CN106138003A CN 106138003 A CN106138003 A CN 106138003A CN 201610540918 A CN201610540918 A CN 201610540918A CN 106138003 A CN106138003 A CN 106138003A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/501—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of stable type film coating pre-mix dose and preparation method, described pre-mixing agent includes hydroxypropyl methyl cellulose, hydroxypropyl cellulose phthalate ester, Pulvis Talci, triethyl citrate and xanthan gum.The preparation method of stable type film coating pre-mix dose is, the hydroxypropyl methyl cellulose and the hydroxypropyl cellulose phthalate ester that weigh ormal weight successively are uniformly mixed；Weigh the Pulvis Talci of ormal weight and triethyl citrate again and be slowly added in said mixture be stirred；Finally it is slowly added to purified water be stirred uniformly, being dried and milled processed by final mixture.Improve film-coated humidity resistance and heat stability, preparation process uses the mode that distributed rendering is dried with substep, is conducive to increasing film coating pre-mix dose each component mixing uniformity and structural stability, improves production efficiency.
Description
Technical field
The present invention relates to the adjuvant of a kind of solid preparation medicine, be specifically related to a kind of stable type film coating pre-mix dose and system
Preparation Method.
Background technology
Film coating pre-mix dose is a kind of novel premixing auxiliary material, refers to outside the medicated core such as powder, granule, pill or tablet
The high molecular film material that Surface coating is stable, as far back as the forties in 20th century, existing country begins one's study film coating new technique
And new material.Film coating is conducive to covering the cloth abnormal smells from the patient of medicine, can be used for preparing controlled release, slow releasing preparation, the most also can rise
Act on to protection against the tide, lucifuge, isolation air etc. thus improve the effect of product stability.Compared with traditional sugar-coat, film coating
Technology has the features such as with short production cycle, materials are few.The application of film-coated technique is more and more extensive, has been applied to veterinary drug and has raised
Feed additives field, makes the technology content of animal husbandry product be greatly improved.
But, in prior art, some solid preparation medicated core have hydrophilic group, can be with the polarity hydroxyl of moisture in air
Base forms hydrogen bond or produces the effect of other molecular separating force, shows extremely strong hygroscopicity, and medicine is exposed to the environment of high humility
In, Environmental Water and medical surfaces are combined into inside medicine reacting, cause occurring variable color, soften, the medicine such as caking
Apparent change, deforming upon in Product transport and storing process etc. affects product quality；Even change the effective of medicine
Composition, shortens the shelf-life of medicine.Additionally for some enzyme medicines, easily deactivation under high temperature wet heat condition, therefore
Protection against the tide and thermal stability by film coating increase pharmaceutical preparation are significant.
Summary of the invention
The technical problem to be solved is that film coating humidity resistance is poor and heat stability is poor, it is therefore intended that
A kind of stable type film coating pre-mix dose and preparation method are provided, make film coating have potent hydrothermal stability.
The present invention is achieved through the following technical solutions:
A kind of stable type film coating pre-mix dose, described pre-mixing agent each component content by weight percentage is:
Hydroxypropyl methyl cellulose 10～35 %；
Hydroxypropyl cellulose phthalate ester 10～20 %；
Pulvis Talci 13～20 %；
Triethyl citrate 2～10 %；
Xanthan gum 0.5～2 %
Purified water surplus.
Preferably, described pre-mixing agent each component content by weight percentage is:
Hydroxypropyl methyl cellulose 20～25 %；
Hydroxypropyl cellulose phthalate ester 14～18 %；
Pulvis Talci 15～18 %；
Triethyl citrate 3～5 %；
Xanthan gum 0.6～0.9 %
Purified water surplus.
Described talcous particle diameter is 10～20 um.
The preparation method of a kind of stable type film coating pre-mix dose, specifically comprises the following steps that
(1) weigh the hydroxypropyl methyl cellulose of ormal weight successively and hydroxypropyl cellulose phthalate ester add in container, 40～
Being stirred dark conjunction 20～30 min at 45 DEG C, mixing speed is 800～1000 r/min；
(2) weigh the Pulvis Talci of ormal weight and triethyl citrate again and be slowly added in mixture prepared by step (1), 50
～at a temperature of 60 DEG C, stirring 20～30 min, mixing speed is 800～1000 r/min；
(3) xanthan gum first weighing ormal weight adds in step (2) mixture prepared, is slow added into purified water, 55～
Stirring 50～80 min at a temperature of 70 DEG C, mixing speed is 1500～2000 r/min；
(4) being dried by mixture prepared by step (3), baking temperature is 50～65 DEG C, is dried 60 min；In dry temperature
Degree is to be dried 180 min at 30～40 DEG C；
(5) mixture prepared by step (4) is ground 180 min, sieves.
Hydroxypropyl methyl cellulose is the advantage that a kind of coating filmogen has smooth appearance, good film-forming property, can heat,
Keep stable under light, air and certain humidity.Hydroxypropyl cellulose phthalate ester is as thin film coating material, molecular structure stabilized
Can long term storage, and itself there is certain plasticity, also play the effect of plasticizer when film forming.By regulation hydroxypropyl first
Base cellulose and the different ratio of two kinds of filmogens of hydroxypropyl cellulose phthalate ester, can increase the one-tenth of film coating pre-mix dose
Film, moisture resistance and stability, can keep pre-mixing agent to have certain pliability simultaneously, can reduce the usage amount of plasticizer, have
It is beneficial to reduce crackle, improves the surface flatness of product.Pulvis Talci mainly plays anti-stick fluidizer effect, when thin-film material viscosity mistake
Greatly, it is easy to be adhered, suitable Pulvis Talci can be added to prevent being adhered of granule or tablet.Triethyl citrate can regulate coating
The pliability of film, makes coating membrane be resistant to osmotic pressure bigger produced by permeation enhancers in label in film, it is ensured that medication
Safety, makes clothing film fragility and hardness reduce, reduces the generation of crackle, increase pliability.Pulvis Talci and lemon is added by regulation
The content of lemon triethylenetetraminehexaacetic acid ester, is conducive to increasing coating hardness, improves humidity resistance, have stronger mar proof simultaneously.Xanthan gum
Former can have the strongest heat stability as stabilizer, gelling thickener, film forming agent, by coordinating xanthan gum and Pulvis Talci
Relative amount can effectively improve the heat stability of product.
In the preparation method of stable type film coating pre-mix dose, using multi-step mixing mixing method, the most each component is stirred
Mix more uniform, promote the mutual synergistic action effect of each component；If stirring mixing is uneven, in dried process, moisture is fast
Speed evaporation, different components is reunited, and needs to mix through long grinding, greatly reduces production efficiency,
Add production cost.By using different thermograde dried, the moisture of blending ingredients is quick at relatively high temperatures
Evaporation, then by being slowly dried under lower temperature conditions, not only improve film coating internal structure stable, accelerate simultaneously
Dried efficiency.
The present invention compared with prior art, has such advantages as and beneficial effect:
1, one stable type film coating pre-mix dose of the present invention, by regulating each component proportion, is effectively improved film coating
Humidity resistance, improve solid preparation medicine structural stability, preventing and treating medicine do not go bad because of the moisture absorption；
2, one stable type film coating pre-mix dose of the present invention, can effectively improve the heat stability being wrapped by sample, prevent sample
Product in preparation process, there is deactivation because of high-temperature steam；
3, one stable type film coating pre-mix dose of the present invention, decreases the generation of crackle, has stronger pliability and wear-resisting
Damage property；
4, the preparation method of a kind of stable type of present invention film coating pre-mix dose, does not has the component proportion of complexity, and preparation process
Use the mode that distributed rendering is dried with substep, be conducive to increasing film coating pre-mix dose each component mixing uniformity and structure is steady
Qualitative, improve production efficiency.
Detailed description of the invention
For making the object, technical solutions and advantages of the present invention clearer, below in conjunction with embodiment, the present invention is made
Further describing in detail, the exemplary embodiment of the present invention and explanation thereof are only used for explaining the present invention, are not intended as this
The restriction of invention.
Embodiment 1
One stable type film coating pre-mix dose of the present invention, pre-mixing agent each component content by weight percentage is:
Hydroxypropyl methyl cellulose 35 %, hydroxypropyl cellulose phthalate ester 10 %, particle diameter is the Pulvis Talci 20% of 10 um, citric acid
Triethyl 10 %, xanthan gum 0.5 %, surplus is purified water.
The preparation method of stable type film coating pre-mix dose, specifically comprises the following steps that
(1) hydroxypropyl methyl cellulose and the hydroxypropyl cellulose phthalate ester that weigh ormal weight successively add in container, at 42 DEG C
Under be stirred 20 min, mixing speed is 800 r/min；
(2) weigh the Pulvis Talci of ormal weight and triethyl citrate again and be slowly added in mixture prepared by step (1), 50
Stirring 20 min at a temperature of DEG C, mixing speed is 800 r/min；
(3) xanthan gum first weighing ormal weight adds in mixture prepared by step (2), is slow added into purified water, at 50 DEG C
At a temperature of stir 50 min, mixing speed is 1500 r/min；
(4) being dried by mixture prepared by step (3), baking temperature is 50 DEG C, is dried 60 min；Then, in dry temperature
Degree is to be dried 180 min at 30 DEG C；
(5) mixture prepared by step (4) being ground 180 min, sieve 200 mesh.
Embodiment 2
One stable type film coating pre-mix dose of the present invention, pre-mixing agent each component content by weight percentage is:
Hydroxypropyl methyl cellulose 20 %；Hydroxypropyl cellulose phthalate ester 15 %；Particle diameter is Pulvis Talci 16 % of 12 um；Fructus Citri Limoniae
Triethylenetetraminehexaacetic acid ester 7 %；Xanthan gum 1.2 % surplus is purified water.
The preparation method of stable type film coating pre-mix dose, specifically comprises the following steps that
(1) hydroxypropyl methyl cellulose and the hydroxypropyl cellulose phthalate ester that weigh ormal weight successively add in container, at 40 DEG C
Under be stirred 20 min, mixing speed is 900 r/min；
(2) weigh the Pulvis Talci of ormal weight and triethyl citrate again and be slowly added in mixture prepared by step (1), 55
Stirring 25 min at a temperature of DEG C, mixing speed is 900 r/min；
(3) xanthan gum first weighing ormal weight adds in mixture prepared by step (2), is slow added into purified water, at 65 DEG C
At a temperature of stir 60 min, mixing speed is 1800 r/min；
(4) being dried by mixture prepared by step (3), baking temperature is 60 DEG C, is dried 60 min；Then, in dry temperature
Degree is to be dried 180 min at 35 DEG C；
(5) mixture prepared by step (4) being ground 180 min, sieve 200 mesh.
Embodiment 3
One stable type film coating pre-mix dose of the present invention, pre-mixing agent each component content by weight percentage is:
Hydroxypropyl methyl cellulose 10 %；Hydroxypropyl cellulose phthalate ester 20 %；Particle diameter is Pulvis Talci 13 % of 15 um；Fructus Citri Limoniae
Triethylenetetraminehexaacetic acid ester 2 %；Xanthan gum 3 %, surplus is purified water.
The preparation method of stable type film coating pre-mix dose, specifically comprises the following steps that
(1) hydroxypropyl methyl cellulose and the hydroxypropyl cellulose phthalate ester that weigh ormal weight successively add in container, at 45 DEG C
Under be stirred mixing 30 min, mixing speed is 1000 r/min；
(2) weigh the Pulvis Talci of ormal weight and triethyl citrate again and be slowly added in mixture prepared by step (1), 60
Stirring 20 min at a temperature of DEG C, mixing speed is 1000 r/min；
(3) xanthan gum first weighing ormal weight adds in mixture prepared by step (2), is slow added into purified water, at 70 DEG C
At a temperature of stir 50 min, mixing speed is 2000 r/min；
(4) being dried by mixture prepared by step (3), baking temperature is 65 DEG C, is dried 60 min；Then, in dry temperature
Degree is to be dried 180 min at 40 DEG C；
(5) mixture prepared by step (4) being ground 180 min, sieve 200 mesh.
Humidity resistance is tested: choose and easily moisture absorption sodium butyrate granule, as subjects, prepares by above example respectively
Thin film coating material be coated, under the conditions of temperature is 40 DEG C, relative humidity is to carry out 30 d by a definite date under conditions of 80%
Accelerate humidity resistance test, weigh every 10 d timings and calculate suction rate of body weight gain.
Sodium butyrate granule moisture absorption rate of body weight gain result (%) in table 1 accelerated test
| Time (d) | Embodiment 1 | Embodiment 2 | Embodiment 3 |
| 10 | 0.27 | 0.23 | 0.25 |
| 20 | 2.38 | 1.87 | 2.91 |
| 30 | 3.92 | 2.95 | 4.10 |
Result shows, by regulating each component proportion, is effectively improved film-coated humidity resistance, improves solid preparation medicine
The structural stability of thing.
Thermostability is tested: choose phytase granule as experimental subject, the film coating prepared by above example respectively
Agent is coated.Being 80 DEG C in temperature, relative humidity is to carry out heat-resistant stability test under conditions of 50 %, and the testing time is
30 min。
Phytase survival results (%) in the test of table 2 thermostability
| Time (min) | Embodiment 1 | Embodiment 2 | Embodiment 3 |
| 10 | 92 | 96 | 93 |
| 20 | 75 | 79 | 71 |
| 30 | 58 | 61 | 53 |
Result shows, stable type film coating has stronger damp and hot stable type.
Above-described detailed description of the invention, has been carried out the purpose of the present invention, technical scheme and beneficial effect further
Describe in detail, be it should be understood that the detailed description of the invention that the foregoing is only the present invention, be not intended to limit the present invention
Protection domain, all within the spirit and principles in the present invention, any modification, equivalent substitution and improvement etc. done, all should comprise
Within protection scope of the present invention.
Claims (4)
1. a stable type film coating pre-mix dose, it is characterised in that described pre-mixing agent each component content by weight percentage
For:
Hydroxypropyl methyl cellulose 10～35 %；
Hydroxypropyl cellulose phthalate ester 10～20 %；
Pulvis Talci 13～20 %；
Triethyl citrate 2～10 %；
Xanthan gum 0.5～2 %
Purified water surplus.
A kind of stable type film coating pre-mix dose the most according to claim 1, it is characterised in that described pre-mixing agent is by weight
Percentages each component content is:
Hydroxypropyl methyl cellulose 20～25 %；
Hydroxypropyl cellulose phthalate ester 14～18 %；
Pulvis Talci 15～18 %；
Triethyl citrate 3～5 %；
Xanthan gum 0.6～0.9 %
Purified water surplus.
A kind of stable type film coating pre-mix dose the most according to claim 1, it is characterised in that described talcous particle diameter
It is 10～15 um.
4. the preparation method of the stable type film coating pre-mix dose described in an any one of claims 1 to 3, it is characterised in that
Specifically comprise the following steps that
(1) weigh the hydroxypropyl methyl cellulose of ormal weight successively and hydroxypropyl cellulose phthalate ester add in container, 40～
Being stirred 20～30 min at 45 DEG C, mixing speed is 800～1000 r/min；
(2) weigh the Pulvis Talci of ormal weight and triethyl citrate again and be slowly added in mixture prepared by step (1), 50
～at a temperature of 60 DEG C, stirring 20～30 min, mixing speed is 800～1000 r/min；
(3) xanthan gum first weighing ormal weight adds in step (2) mixture prepared, is slow added into purified water, 55～
Stirring 50～80 min at a temperature of 70 DEG C, mixing speed is 1500～2000 r/min；
(4) being dried by mixture prepared by step (3), baking temperature is 50～65 DEG C, is dried 60 min；Then, dry
Dry temperature is to be dried 180 min at 30～40 DEG C；
(5) mixture prepared by step (4) is ground 180 min, sieves.
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| CN201610540918.4A CN106138003A (en) | 2016-07-11 | 2016-07-11 | A kind of stable type film coating pre-mix dose and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610540918.4A CN106138003A (en) | 2016-07-11 | 2016-07-11 | A kind of stable type film coating pre-mix dose and preparation method |
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| CN106138003A true CN106138003A (en) | 2016-11-23 |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1628641A (en) * | 2004-09-09 | 2005-06-22 | 成都市泰山薄膜包衣有限公司 | Enteric coated type thin membrane coated premixed agent and preparation method thereof |
| CN102727458A (en) * | 2011-03-30 | 2012-10-17 | 信越化学工业株式会社 | Coating composition, solid preparation coated therewith, and method for preparing solid preparation |
| CN102935234A (en) * | 2012-09-29 | 2013-02-20 | 广西嘉进药业有限公司 | Film coating medicine and preparation method thereof |
| CN103520733A (en) * | 2013-10-25 | 2014-01-22 | 天津博科林药品包装技术有限公司 | Coating agent capable of overcoming solution sedimentation |
| CN105283204A (en) * | 2013-06-17 | 2016-01-27 | 日本曹达株式会社 | Coating agent containing hydroxyalkyl cellulose |
-
2016
- 2016-07-11 CN CN201610540918.4A patent/CN106138003A/en not_active Withdrawn
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1628641A (en) * | 2004-09-09 | 2005-06-22 | 成都市泰山薄膜包衣有限公司 | Enteric coated type thin membrane coated premixed agent and preparation method thereof |
| CN102727458A (en) * | 2011-03-30 | 2012-10-17 | 信越化学工业株式会社 | Coating composition, solid preparation coated therewith, and method for preparing solid preparation |
| CN102935234A (en) * | 2012-09-29 | 2013-02-20 | 广西嘉进药业有限公司 | Film coating medicine and preparation method thereof |
| CN105283204A (en) * | 2013-06-17 | 2016-01-27 | 日本曹达株式会社 | Coating agent containing hydroxyalkyl cellulose |
| CN103520733A (en) * | 2013-10-25 | 2014-01-22 | 天津博科林药品包装技术有限公司 | Coating agent capable of overcoming solution sedimentation |
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