CN101829334A - Film coating agent for extract medicament solid preparation and preparation method thereof - Google Patents
Film coating agent for extract medicament solid preparation and preparation method thereof Download PDFInfo
- Publication number
- CN101829334A CN101829334A CN201010135389A CN201010135389A CN101829334A CN 101829334 A CN101829334 A CN 101829334A CN 201010135389 A CN201010135389 A CN 201010135389A CN 201010135389 A CN201010135389 A CN 201010135389A CN 101829334 A CN101829334 A CN 101829334A
- Authority
- CN
- China
- Prior art keywords
- coating agent
- film coating
- solid preparation
- preparation
- stearic acid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention relates to a film coating agent for an extract medicament solid preparation, which comprises the following components in parts by weight: 30-60 parts of hydroxypropyl methyl cellulose, 5-30 parts of plasticizer and 2-30 parts of stearic acid. The invention also relates to a preparation method of the film coating agent, which comprises the following steps of: (1) weighing the hydroxypropyl methyl cellulose, the plasticizer and the stearic acid in parts by weight; and (2) adding the hydroxypropyl methyl cellulose, the plasticizer and the stearic acid into a high-speed shearing machine and uniformly mixing the materials at the speed of 350-600 rpm to prepare a coating agent finished product. The coating agent is safe and non-toxic, and can form a hydrophobic molecular layer on the surface of a medicament for inhibiting the adsorption and osmosis of steam on the surface of a coating film, thereby reducing the moisture absorbing rate of a medicament coating tablet and preventing the damping and hardening of the medicament and medicament efficiency loss; meanwhile, the coating film has strong flexibility, and the coating quality is stable; and the preparation method has the outstanding advantages of high production efficiency, low energy consumption, favorable application performance of coating agent finished products, and the like.
Description
Technical field
The invention belongs to the coating materials field, especially a kind of film coating agent that is used for the extract medicament solid preparation and preparation method thereof.
Background technology
A lot of products belong to the extractum sheet in the Chinese medicinal tablet, contain many compositions that are easy to the moisture absorption, and it is subjected to the damp and hot easily softening moisture absorption that influences, and causes the label distortion, the medicine scleroma, and disintegrate fully influences curative effect of medication; And moisture absorption also can cause the caking of preparation, mobile reduction, deliquescence, crystal formation change etc., and then causes that compatibility changes between change color, content reduction or component; Easier oxidated, the hydrolysis of preparation after the moisture absorption, go mouldy, physical stability, chemical stability and the biological stability of preparation are reduced.Therefore concerning extractum class solid preparation, the humidity resistance that improves product is the emphasis of research at present.
For improving the medicine humidity resistance, many scholars have carried out big quantity research, think that the former of medicine moisture absorption combines and the moisture absorption with moisture in the environment because medicine Semi-polarity group (as hydroxyl) sees through intermolecular Van der Waals force or hydrogen bond.For water soluble drug, when envionmental humidity was low, medicine is moisture absorption hardly, and increased to a certain numerical value when above when relative humidity, and then hygroscopic capacity sharply increases.Relative humidity when hygroscopic capacity sharply increases is called the critical relative humidity (CRH) of this medicine.Different medicines all has its oneself critical relative humidity, so under the same conditions, some medicine can show is more prone to the moisture absorption.Simultaneously, envionmental humidity is high more, and the rate of moisture absorption of medicine also can be accelerated.So the method that solves the medicine moisture absorption is for improving the critical relative humidity of medicine self, the medicine rate of moisture absorption slows down.Wherein the Chinese medicine moistureproof coating is an effective method comparatively.
Common coating materials is a filmogen with hydroxypropyl emthylcellulose (HPMC), has stronger water absorption, and its clothing film voidage is bigger.In the higher environment of humidity, aqueous vapor easily on clothing film surface with the hydrophilic group absorption of HPMC, moisture progressively infiltrates clothing film inside, when humidity during greater than critical relative humidity, the quick moisture absorption of medicine.Problems such as so the moisture absorption usually can take place under hygrothermal environment the extract medicament of HPMC prescription coating, expand, ooze out.Many data are mentioned and are adopted crylic acid resin material and HPMC composite, the raising humidity resistance.But acrylic resin is more crisp, and coating membrane regular meeting produces small crackle, and moisture effect is descended.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, a kind of film coating agent that is used for the extract medicament solid preparation is provided, this coating materials can play moisture-proof role to the extract medicament solid preparation that is coated in it, suppress absorption and the infiltration of moisture on clothing film surface, reduce the moisture absorption ratio of pharmaceutical pack garment piece, avoid the medicine hardening of making moist, prevented the drug effect loss.
Another object of the present invention is to provide a kind of film coating agent preparation method that is used for the extract medicament solid preparation.
The present invention solves its technical problem and takes following technical scheme to realize:
A kind of film coating agent that is used for the extract medicament solid preparation, the component of this film coating agent and ratio of weight and number thereof are:
Hydroxypropyl emthylcellulose 30～60;
Plasticizer 5～30;
Stearic acid 2～30.
And described film coating agent also comprises coloring agent, and its content is 15～35 weight portions.
And described coloring agent is titanium dioxide, color lake or ferrum oxide.
And the particle diameter of described coloring agent is between 0.1～20 μ m.
And described plasticizer is Polyethylene Glycol, glycerol, triethyl citrate, Oleum Ricini or diethyl phthalate.
A kind of preparation method that is used for the film coating agent of extract medicament solid preparation, this method may further comprise the steps:
(1) takes by weighing hydroxypropyl emthylcellulose, plasticizer, stearic acid according to the weight fraction ratio;
(2) hydroxypropyl emthylcellulose, plasticizer, stearic acid are added in the high-speed shearing machine, make mixing of materials even, make the coating materials finished product with 350～600 rev/mins speed.
And this method is further comprising the steps of: take by weighing coloring agent in step (1); After in step (2), adding the coloring agent mix homogeneously, the high speed shear motor speed is brought up to 900～1200 rev/mins, coloring agent is fully disperseed, make the coating materials finished product.
Advantage of the present invention and good effect are:
1. included stearic acid has nontoxic, non-irritating characteristics in the coating materials of the present invention, is applicable to the drug coating agent; And the stearic acid molecular weight is less, has lubricated and plasticization, is evenly distributed in the coating materials prescription between the HPMC strand, well merges with HPMC, has reduced the permeability of clothing film; And on clothing film surface, formed one deck hydrophobic molecule layer, make hydrone be difficult in its surface adsorption, increased the resistance to mass tranfer that moisture infiltrates, clothing film internal medium humidity is less than the critical relative humidity of medicine, the medicine rate of moisture absorption has obtained effective control, therefore stearic acid and HPMC preparation is formed compound coating materials, can play good moisture-proof role; The clothing film has good flexible simultaneously, splintering problem can not take place.
2. the preparation method of coating materials of the present invention, under the low velocity shear condition, finish the abundant mixing of membrane and the uniform distribution of plasticizer, and the dry method of finishing coloring agent under the high speed shear condition is disperseed, can avoid coloring agent to reunite, have outstanding advantages such as production efficiency height, energy consumption is low, coating materials finished product application performance is good.
3. coating materials safety of the present invention, nontoxic can form one deck hydrophobic molecule layer at medical surfaces, suppresses absorption and the infiltration of aqueous vapor on clothing film surface, thereby reduces pharmaceutical pack garment piece moisture absorption ratio, avoids medicine make moist hardening and drug effect loss; Clothing film pliability is strong simultaneously, and coating quality is stable; Its preparation method has outstanding advantages such as production efficiency height, energy consumption is low, coating materials finished product application performance is good.
The specific embodiment
Be further described below in conjunction with embodiment, following examples are descriptive, are not determinate, can not limit protection scope of the present invention with this.
1. moisture absorption method of testing: use coating materials to carry out coating extract medicament, the thin membrane coated tablet that makes is put into 40 ℃, the climatic chamber of 75% humidity, the highest moisture absorption ratio and the cosmetic variation situation of record medicine.
The ordinary coating agent prescription: hydroxypropyl emthylcellulose 60 grams, Polyethylene Glycol 10 grams, titanium dioxide 30 grams make the coating materials finished product behind the mix homogeneously.This coating materials finished product adopts the moisture absorption method of testing among the present invention to test, and the accelerated tests medicine moisture absorption ratio of gained is 8.27%.
Embodiment 1
A kind of film coating agent that is used for the extract medicament solid preparation, the weight of its component and each component is:
Hydroxypropyl emthylcellulose 50 grams;
Diethyl phthalate 30 grams;
Stearic acid 20 grams.
The step of the preparation method of the above-mentioned film coating agent that is used for the extract medicament solid preparation is:
(1) takes by weighing hydroxypropyl emthylcellulose 50 grams, diethyl phthalate 30 grams, stearic acid 20 grams;
(2) hydroxypropyl emthylcellulose that takes by weighing, diethyl phthalate, stearic acid are added in the high-speed shearing machine, make mixing of materials even with 350 rev/mins speed, make the coating materials finished product, its production efficiency height, energy consumption are lower.
Do not use coloring agent in the present embodiment, can form transparent clothing film, reflect the original appearance characteristics of product.
The coating materials finished product that present embodiment prepares gained adopts the moisture absorption method of testing among the present invention to test, and the accelerated tests medicine moisture absorption ratio of gained is 6.17%, obviously descends than the moisture absorption ratio of ordinary coating agent.
Embodiment 2
A kind of film coating agent that is used for the extract medicament solid preparation, the weight of its component and each component is:
Hydroxypropyl emthylcellulose 30 grams;
Polyethylene Glycol 5 grams;
Stearic acid 30 grams;
Titanium dioxide 35 grams.
The step of the preparation method of the above-mentioned film coating agent that is used for the extract medicament solid preparation is:
(1) takes by weighing hydroxypropyl emthylcellulose 30 grams, Polyethylene Glycol 5 grams, stearic acid 30 grams, titanium dioxide 35 grams successively;
(2) hydroxypropyl emthylcellulose, Polyethylene Glycol, stearic acid, the titanium dioxide that takes by weighing added in the high-speed shearing machine, make mixing of materials even with 500 rev/mins speed;
(3) the high speed shear motor speed is brought up to 900 rev/mins, the titanium dioxide particle diameter is 10～20 μ m, and coloring agent fully disperses, and obtains the coating materials finished product of color even.
The coating materials finished product that present embodiment prepares gained adopts the moisture absorption method of testing among the present invention to test, and the accelerated tests medicine moisture absorption ratio of gained is 4.05%.Stearic acid adds the content height in the prescription, forms hydrophobic layer, has stoped moisture to enter, and obviously descends than the moisture absorption ratio of ordinary coating agent.
Embodiment 3
A kind of film coating agent that is used for the extract medicament solid preparation, the weight of its component and each component is:
Hydroxypropyl emthylcellulose 60 grams;
Oleum Ricini 15 grams;
Stearic acid 2 grams;
Color lake 23 grams.
The step of the preparation method of the above-mentioned film coating agent that is used for the extract medicament solid preparation is:
(1) takes by weighing hydroxypropyl emthylcellulose 60 grams, Oleum Ricini 15 grams, stearic acid 2 grams, color lake 23 grams successively;
(2) hydroxypropyl emthylcellulose, Oleum Ricini, stearic acid, the color lake that takes by weighing added in the high-speed shearing machine, make mixing of materials even with 500 rev/mins speed;
(3) the high speed shear motor speed is brought up to 1000 rev/mins, the color lake particle diameter is 1～10 μ m, and coloring agent fully disperses, and obtains the coating materials finished product of color even.
The coating materials finished product that present embodiment prepares gained adopts the moisture absorption method of testing among the present invention to test, and the accelerated tests medicine moisture absorption ratio of gained is 7.94%.Moisture absorption ratio than the ordinary coating agent descends to some extent.
Embodiment 4
A kind of film coating agent that is used for the extract medicament solid preparation, the weight of its component and each component is:
Hydroxypropyl emthylcellulose 45 grams;
Triethyl citrate 25 grams;
Stearic acid 15 grams;
Ferrum oxide 15 grams.
The step of the preparation method of the above-mentioned film coating agent that is used for the extract medicament solid preparation is:
(1) takes by weighing hydroxypropyl emthylcellulose 45 grams, triethyl citrate 25 grams, stearic acid 15 grams, ferrum oxide 15 grams successively;
(2) hydroxypropyl emthylcellulose, triethyl citrate, stearic acid, the ferrum oxide that takes by weighing added in the high-speed shearing machine, make mixing of materials even with 600 rev/mins speed;
(3) the high speed shear motor speed is brought up to 1200 rev/mins, the color lake particle diameter is 0.1～1 μ m, and coloring agent fully disperses, and obtains the coating materials finished product of color even.
The coating materials finished product that present embodiment prepares gained adopts the moisture absorption method of testing among the present invention to test, and the accelerated tests medicine moisture absorption ratio of gained is 6.22%, obviously descends than the moisture absorption ratio of ordinary coating agent.
As seen, behind the adding stearic acid, can effectively avoid absorption and the infiltration of steam at the film surface of coated tablet in coating materials, the penetrating rate of the steam of thin film has had obvious decline, thereby the medicine rate of moisture absorption is reduced, and plays moisture-proof role.
The plasticizer that is adopted in the film coating agent of the present invention can also be glycerol, no longer enumerates at this.
Claims (7)
1. film coating agent that is used for the extract medicament solid preparation, it is characterized in that: the component of this film coating agent and ratio of weight and number thereof are:
Hydroxypropyl emthylcellulose 30～60;
Plasticizer 5～30;
Stearic acid 2～30.
2. the film coating agent that is used for the extract medicament solid preparation according to claim 1 is characterized in that: described film coating agent also comprises coloring agent, and its content is 15～35 weight portions.
3. the film coating agent that is used for the extract medicament solid preparation according to claim 2 is characterized in that: described coloring agent is titanium dioxide, color lake or ferrum oxide.
4. according to claim 2 or the 3 described film coating agents that are used for the extract medicament solid preparation, it is characterized in that: the particle diameter of described coloring agent is between 0.1～20 μ m.
5. the film coating agent that is used for the extract medicament solid preparation according to claim 1 is characterized in that: described plasticizer is Polyethylene Glycol, glycerol, triethyl citrate, Oleum Ricini or diethyl phthalate.
6. preparation method that is used for the film coating agent of extract medicament solid preparation, it is characterized in that: this method may further comprise the steps:
(1) takes by weighing hydroxypropyl emthylcellulose, plasticizer, stearic acid according to the weight fraction ratio;
(2) hydroxypropyl emthylcellulose, plasticizer, stearic acid are added in the high-speed shearing machine, make mixing of materials even, make the coating materials finished product with 350～600 rev/mins speed.
7. the preparation method that is used for the film coating agent of extract medicament solid preparation according to claim 6 is characterized in that: this method is further comprising the steps of: take by weighing coloring agent in step (1); After in step (2), adding the coloring agent mix homogeneously, the high speed shear motor speed is brought up to 900～1200 rev/mins, coloring agent is fully disperseed, make the coating materials finished product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101353892A CN101829334B (en) | 2010-03-30 | 2010-03-30 | Film coating agent for extract medicament solid preparation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101353892A CN101829334B (en) | 2010-03-30 | 2010-03-30 | Film coating agent for extract medicament solid preparation and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101829334A true CN101829334A (en) | 2010-09-15 |
| CN101829334B CN101829334B (en) | 2012-07-18 |
Family
ID=42713651
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2010101353892A Active CN101829334B (en) | 2010-03-30 | 2010-03-30 | Film coating agent for extract medicament solid preparation and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101829334B (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103012855A (en) * | 2012-12-14 | 2013-04-03 | 湖北中烟工业有限责任公司 | Thin-film coating agent of essence pellet for cigarette and preparation method of thin-film coating agent |
| CN105125516A (en) * | 2015-10-19 | 2015-12-09 | 安阳天助药业有限责任公司 | Enteric coating type medicine film coating pre-mixing agent and preparing method |
| CN105521493A (en) * | 2014-09-28 | 2016-04-27 | 天津尖峰弗兰德医药科技发展有限公司 | Film coating premixing auxiliary material |
| CN112655969A (en) * | 2021-03-15 | 2021-04-16 | 江苏艾兰得营养品有限公司 | Choline bitartrate granules, tablets containing same and preparation method |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109260321B (en) * | 2018-11-26 | 2021-08-13 | 广东新峰药业股份有限公司 | Houjiling film-coated tablet and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1466450A (en) * | 2000-09-06 | 2004-01-07 | CHR��ɭ��˾ | Dry-powder film coating composition and method of preparation |
| CN1156271C (en) * | 2000-04-29 | 2004-07-07 | 中国科学技术大学 | Macromolecular coating powder for solid medicine preparation and its preparation method |
| CN101361979A (en) * | 2008-09-19 | 2009-02-11 | 天津博科林药品包装技术有限公司 | Solid preparation film coating agent and preparation method thereof |
-
2010
- 2010-03-30 CN CN2010101353892A patent/CN101829334B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1156271C (en) * | 2000-04-29 | 2004-07-07 | 中国科学技术大学 | Macromolecular coating powder for solid medicine preparation and its preparation method |
| CN1466450A (en) * | 2000-09-06 | 2004-01-07 | CHR��ɭ��˾ | Dry-powder film coating composition and method of preparation |
| CN101361979A (en) * | 2008-09-19 | 2009-02-11 | 天津博科林药品包装技术有限公司 | Solid preparation film coating agent and preparation method thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103012855A (en) * | 2012-12-14 | 2013-04-03 | 湖北中烟工业有限责任公司 | Thin-film coating agent of essence pellet for cigarette and preparation method of thin-film coating agent |
| CN103012855B (en) * | 2012-12-14 | 2015-10-21 | 湖北中烟工业有限责任公司 | Film coating agent of flavouring essence for tobacco micropill and preparation method thereof |
| CN105521493A (en) * | 2014-09-28 | 2016-04-27 | 天津尖峰弗兰德医药科技发展有限公司 | Film coating premixing auxiliary material |
| CN105125516A (en) * | 2015-10-19 | 2015-12-09 | 安阳天助药业有限责任公司 | Enteric coating type medicine film coating pre-mixing agent and preparing method |
| CN112655969A (en) * | 2021-03-15 | 2021-04-16 | 江苏艾兰得营养品有限公司 | Choline bitartrate granules, tablets containing same and preparation method |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101829334B (en) | 2012-07-18 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Zhang et al. | Zein-based films and their usage for controlled delivery: Origin, classes and current landscape | |
| CN101829334B (en) | Film coating agent for extract medicament solid preparation and preparation method thereof | |
| CN102138870B (en) | Collagen facial mask and preparation method thereof | |
| CN102847163B (en) | Film coating agent for hygroscopic solid traditional Chinese medicine preparation and preparation method thereof | |
| Su et al. | Preparation and characterization of ethyl cellulose film modified with capsaicin | |
| CN104666275B (en) | Starch-based plant empty capsule | |
| CN101885853A (en) | Cured cross-linked glutinous rice flour hydrogel, preparation method and application thereof | |
| CN105380924B (en) | A kind of chitosan oligosaccharide capsule agent and preparation method thereof | |
| CN105496981B (en) | A kind of chitosan oligosaccharide tablet and preparation method thereof | |
| US20210196641A1 (en) | Soft Capsule Film Composition | |
| CN101024086A (en) | Composition formed from chitosan and its derivatives and low-molecular heparin and pneparation and preparing method | |
| CN102058562A (en) | Method for preparing gamma-polyglutamic acid/chitosan nano capsules | |
| CN106727044A (en) | A kind of bamboo charcoal oil control and acne removal facial mask | |
| CN106389137A (en) | Flaxseed oil liposome and preparation and applications thereof | |
| KR101805171B1 (en) | Biocellulose paper and manufacturing method thereof | |
| CN103520114B (en) | Nuciferine microsphere and preparation method thereof | |
| CN103191441B (en) | Method for preparing stimuli-response type esterified nano cellulose prodrug sustained-release material | |
| CN102499891B (en) | Moisture-proof preparation method for solvent-free solid preparation | |
| CN101569615A (en) | Film coating agent used for exudative solid preparation and method for preparing same | |
| EP3552629A1 (en) | Hard capsule showing improved deposition of gelling adjuvant and method for preparation thereof | |
| EP3023096A1 (en) | Soft capsule coating | |
| Kumar et al. | Introduction to Alginate: Biocompatible, Biodegradable, Antimicrobial Nature and Various Applications | |
| CN114081869B (en) | Microcapsule-embedded chitosan solid fragrance and preparation method and application thereof | |
| CN103127003B (en) | Omeprazole enteric micropelets and capsule as well as preparation method thereof | |
| Gea et al. | Bacterial cellulose impregnated with andaliman (Zanthoxylum acanthopodium) microencapsulation as diabetic wound dressing |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |