CN104940946A - Coating composition, coated drug preparation prepared from same and preparation method of coated drug preparation - Google Patents
Coating composition, coated drug preparation prepared from same and preparation method of coated drug preparation Download PDFInfo
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- CN104940946A CN104940946A CN201410130730.3A CN201410130730A CN104940946A CN 104940946 A CN104940946 A CN 104940946A CN 201410130730 A CN201410130730 A CN 201410130730A CN 104940946 A CN104940946 A CN 104940946A
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Abstract
The invention provides a coating composition comprising zein, pectin and a plasticizer. The invention also provides a coated drug preparation and a preparation method thereof. The coating composition provided by the invention contains natural polymer zein and pectin, is good in stability and water resistance, and can effectively realize controlled release of a drug. The coated drug preparation provided by the invention adopts the coating composition for coating film coating, so that the controlled release of the drug at different time and different parts can be realized. The preparation method of the coated drug preparation provided by the invention is simple, is good in film forming property, and has a great potential for industrial application.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of comprise natural high molecular substance coated composition and the coated pharmaceutical preparation adopting this coated composition to make and preparation method.
Background technology
Drug controlled release utilizes natural or macromolecular compound as pharmaceutical carrier, controls the release of medicine in human body, make medicine slow releasing in certain hour scope and speed, reaches the object of certain disease for the treatment of.Relative to routine release, the advantage of Co ntrolled release comprises: (1) can control the concentration of medicine effectively, avoids neglecting high, suddenly low situation appearance and the generation of toxic and side effects; (2) utilization ratio of drug is higher than conventional release; (3) off-position is close to source of disease, thus improves drug effect, avoids systemic side effects; (4) can times for spraying be reduced, thus reduce side effect.Control release technic, except being applied in except medical science, can also being applied, develop in pesticide, fertilizer, cosmetics and food additive etc.
Zein is the major storage albumen in Semen Maydis, and its molecule has a large amount of hydrophobic amino acid, and is rich in sulfur-containing amino acid, and it is water insoluble, but can be dissolved in the alcohol solution of 60 ~ 95%.Sulfur-containing amino acid in zein makes the disulfide bond between protein molecule, hydrophobic bond is connected, and orders about the formation of thin film.Through solvent volatilization, protein concentration increases, and forms film web.After zein film forming, stablize in acid condition, unstable in neutral and alkaline conditions, therefore there is enteric solubility, be commonly used for enteric coating.At present in the material of drug controlled release, widely use gelatin and enteric coating, to realize the effectiveness of Co ntrolled release.But its disintegration is undesirable, due to factors such as external environment instability, affect the effect of Co ntrolled release.
Pectin is a kind of macromolecule polysaccharide, is made up of different units chain link, is extensively present in the inside of plant cell as support substance.Pectin is white powder, can be water-soluble, but is insoluble to ethanol.Pectin, in the process of dissolving, is first swelling, then dissolves and form viscous solution.Because the viscosity of pectin and gelling, it is widely used in fruit jam, fruit jelly, Yoghourt, beverage concentrate and pan work etc.
Summary of the invention
For overcoming the defect existed in existing drug controlled release, an object of the present invention is to provide a kind of stability and water-resistance is good, can realize the coated composition of drug controlled release.
Another object of the present invention is to provide a kind of coated pharmaceutical preparation.
An also object of the present invention is to provide a kind of preparation method of coated pharmaceutical preparation.
Coated composition provided by the invention, comprises following composition by weight:
Zein: 1 part;
Pectin: 0.01 ~ 5 part; And
Plasticizer: 0.1 ~ 2 part.
Preferably, described coated composition, comprises following composition by weight:
Zein: 1 part;
Pectin: 0.1 ~ 1 part; And
Plasticizer: 0.5 ~ 1 part.
Wherein, described plasticizer is selected from one or more in oleic acid, linoleic acid, linolenic acid, stearic acid, glycerol, Polyethylene Glycol, 2,2'-ethylenedioxybis(ethanol)..
Coated pharmaceutical preparation provided by the invention, it comprises the coating that the coated composition described in solid pharmaceutical preparation and technique scheme is formed.
Wherein, described solid pharmaceutical preparation is the pharmaceutical preparation of stomach and/or colon release administration.
The preparation method of described coated pharmaceutical preparation provided by the invention comprises the following steps:
(1) zein, pectin and plasticizer are dissolved in solvent form coating solution;
(2) solid pharmaceutical preparation is placed in described coating solution and carries out film, volatilize solvent, obtain described coated pharmaceutical preparation.
Wherein, the solvent in described step (1) is aqueous solutions of organic solvent, and the mass ratio of described aqueous solutions of organic solvent and described zein is 1:3 ~ 6.
Wherein, described organic solvent is selected from one or more in ethanol, propanol, isopropyl alcohol, butanediol, amylalcohol, formic acid, acetic acid, lactic acid, acetone.
Wherein, the film-coating procedures of described step (2) is 1 ~ 3 time, and the time of each film is 2 ~ 10 seconds.
Another preparation method of described coated pharmaceutical preparation provided by the invention comprises the following steps:
(1) zein and plasticizer are dissolved in solvent form coating solution A, by formation coating solution B soluble in water for pectin;
(2) solid pharmaceutical preparation is placed in successively described coating solution B, coating solution A carries out film, volatilize solvent, obtain described coated pharmaceutical preparation.
Wherein, the solvent in described step (1) is aqueous solutions of organic solvent, and the mass ratio of described aqueous solutions of organic solvent and described zein is 1:3 ~ 6.
Wherein, described organic solvent is selected from one or more in ethanol, propanol, isopropyl alcohol, butanediol, amylalcohol, formic acid, acetic acid, lactic acid, acetone.。
Wherein, in described coating solution B, the mass percent concentration of pectin is 1 ~ 5%.
Wherein, described coating solution B also comprises the plasticizer that mass percent concentration is 0.1 ~ 1%.
Wherein, described plasticizer is selected from one or more in oleic acid, linoleic acid, linolenic acid, stearic acid, glycerol, Polyethylene Glycol, 2,2'-ethylenedioxybis(ethanol)..
Wherein, the film-coating procedures of described step (2) is 1 ~ 3 time, and the time of each film is 2 ~ 10 seconds.
Containing natural polymer corn in coated composition provided by the invention, for the animality raw materials such as gelatin and the material such as cellulose, starch common medicinal adjuvant, the zein of originating species not easily produces chemical action with air, water etc., reduce the impact of external environment, the dependency of packaging is also obviously reduced, stability and water-resistance higher, and with low cost, wide material sources, bio-compatible.Also containing pectin in coated composition provided by the invention, itself and zein immixture, by change content, the time of effective Drug controlled release.Coated composition provided by the invention extends the application of vegetalitas raw material in medicament protection and Co ntrolled release.
The coated composition that coated pharmaceutical preparation provided by the invention have employed containing natural polymer corn and pectin carries out coating film, by the content of zein and pectin in adjustment compositions, the Co ntrolled release of medicine at different time, different parts can be realized, especially achieve at human colorectal Co ntrolled release, extend the application of natural polymer corn in the release of medicine Colon and rectum.
Coated pharmaceutical preparation preparation method provided by the invention is simple, and good film-forming property, has the great potential of industrial applications.
Accompanying drawing explanation
The release profiles of coated pharmaceutical preparation in simulated gastric fluid and intestinal juice the active component vitamin C of Fig. 1 prepared by different concentration of pectin;
Wherein, curve 1-3 represents the release profiles of embodiment 2,1 and the pharmaceutical preparation of comparative example gained respectively;
Drug release in first two hours simulated gastric fluid, the drug release in six hours thereafter simulated intestinal fluids.
Fig. 2 is the embodiment 3 gained coated pharmaceutical preparation release profiles of vitamin C in simulated gastric fluid, intestinal juice and Colon and rectum respectively;
Wherein, curve 4 represents the release profiles of embodiment 3 gained pharmaceutical preparation;
Drug release in first two hours simulated gastric fluid, the drug release in four hours thereafter simulated intestinal fluids, the drug release in last 18 hours simulation Colon and rectum.
Detailed description of the invention
For making the object, technical solutions and advantages of the present invention clearly, will be further described below the technical scheme of exemplary embodiment of the present invention.
One aspect of the present invention provides a kind of coated composition, comprises zein, pectin and plasticizer.Zein has good antioxidation and water-resistance, relative to existing coating substance good stability, zein and pectin are by the composition of different proportion, can change its degradation speed in gastric juice, intestinal juice, the coated preparation thus adopting this coated composition to be formed can realize the Co ntrolled release of medicine at different time, different parts.
In an embodiment of coated composition according to the present invention, this coated composition can comprise by weight:
Zein: 1 part;
Pectin: 0.01 ~ 5 part; And
Plasticizer: 0.1 ~ 2 part.
In an embodiment of coated composition according to the present invention, this coated composition can comprise by weight:
Zein: 1 part;
Pectin: 0.1 ~ 1 part; And
Plasticizer: 0.5 ~ 1 part.
In an embodiment of coated composition according to the present invention, plasticizer can be one or more in oleic acid, linoleic acid, linolenic acid, stearic acid, glycerol, Polyethylene Glycol, 2,2'-ethylenedioxybis(ethanol)..
Another aspect of the present invention provides a kind of coated pharmaceutical preparation, and it comprises the coating that the coated composition described in solid pharmaceutical preparation and technique scheme is formed.
In an embodiment of coated pharmaceutical preparation according to the present invention, solid pharmaceutical preparation can be the pharmaceutical preparation of stomach and/or colon release administration.
In an embodiment of coated pharmaceutical preparation according to the present invention, solid pharmaceutical preparation can be the common solid dosage form of pharmaceutical field, includes but not limited to tablet, pill, granule etc.
Present invention also offers the preparation method of foregoing coatings pharmaceutical preparation, comprise the following steps:
(1) zein, pectin and plasticizer are dissolved in solvent form coating solution;
(2) solid pharmaceutical preparation is placed in described coating solution and carries out film, volatilize solvent, obtain coated pharmaceutical preparation.
Wherein, solvent does not limit kind or composition, can dissolve zein and pectin and be easy to volatilize.
In an embodiment of preparation in accordance with the present invention, the solvent in step (1) can be aqueous solutions of organic solvent, and the mass ratio of aqueous solutions of organic solvent and zein can be 1:3 ~ 6.
In an embodiment of preparation in accordance with the present invention, organic solvent can be one or more in ethanol, propanol, isopropyl alcohol, butanediol, amylalcohol, formic acid, acetic acid, lactic acid, acetone.The solvent preferred volume concentration of step (1) is the alcohol solution of 80 ~ 95%.
In an embodiment of preparation in accordance with the present invention, the film-coating procedures of step (2) is 1 ~ 3 time, and the time of each film is 2 ~ 10 seconds.Solid pharmaceutical preparation is immersed in coating solution after film at every turn, take out volatilization except desolventizing, again carry out film-coating procedures next time.
In an embodiment of preparation in accordance with the present invention, the thickness of film can adjust according to film forming composition and required drug release situation, usually can be 100 ~ 200 microns, but be not limited thereto.
Present invention also offers the preparation method of another kind of foregoing coatings pharmaceutical preparation, comprise the following steps:
(1) zein and plasticizer are dissolved in solvent form coating solution A, by formation coating solution B soluble in water for pectin;
(2) solid pharmaceutical preparation is placed in successively described coating solution B, coating solution A carries out film, volatilize solvent, obtain coated pharmaceutical preparation.
Wherein, solvent does not limit kind or composition, can dissolve zein and pectin and be easy to volatilize.
In an embodiment of preparation in accordance with the present invention, the solvent in step (1) can be aqueous solutions of organic solvent, and the mass ratio of aqueous solutions of organic solvent and zein can be 1:3 ~ 6.
In an embodiment of preparation in accordance with the present invention, organic solvent can be one or more in ethanol, propanol, isopropyl alcohol, butanediol, amylalcohol, formic acid, acetic acid, lactic acid, acetone.The solvent preferred volume concentration of step (1) is the alcohol solution of 80 ~ 95%.
In an embodiment of preparation in accordance with the present invention, in coating solution B, the mass percent concentration of pectin can be 1 ~ 5%.
In an embodiment of preparation in accordance with the present invention, coating solution B can also comprise the plasticizer that mass percent concentration is 0.1 ~ 1%.
In an embodiment of preparation in accordance with the present invention, plasticizer in coating solution B can be one or more in oleic acid, linoleic acid, linolenic acid, stearic acid, glycerol, Polyethylene Glycol, 2,2'-ethylenedioxybis(ethanol)., it can be identical with the plasticizer kind in coating solution A, also can be different.In an embodiment of preparation in accordance with the present invention, the film-coating procedures of step (2) is 1 ~ 3 time, and the time of each film is 2 ~ 10 seconds.Solid pharmaceutical preparation is immersed in coating solution B, A after film successively at every turn, take out volatilization except desolventizing, again carry out film-coating procedures next time.
In an embodiment of preparation in accordance with the present invention, the thickness of film can adjust according to film forming composition and required drug release situation, usually can be 100 ~ 200 microns, but be not limited thereto.
In two kinds of preparation methoies provided by the invention, the relative impact that should not be subject to gastric juice of membrane structure that the method for zein and pectin film forming respectively obtains, is particularly useful for the coating of Colon and rectum administration medicine preparation.Zein mixes film forming method with pectin is then more applicable for the structure adjusting film according to pectin content, thus is more applicable for the release of control medicine at different parts, different time.
In following examples, comparative example and test, all material is commercially available purchase product if no special instructions, and described operation is this area routine operation if no special instructions.
Wherein, tablet used is commercially available vitamin C tablet, and zein (CAS:9010-66-6) is purchased from Sigma-Aldrich, and pectin (CAS:9000-69-5) is purchased from West Asia, Chengdu chemical technology company.
Embodiment 1
At normal temperatures and pressures, take 10g zein and be dissolved in 50ml80%(v/v) alcoholic solution in, be stirred to most zein with Glass rod to dissolve, add 7ml oleic acid, it is transparent that constant temperature blender with magnetic force is stirred to dissolution homogeneity with the speed of 600rpm/min.Take 1.0g pectin, add zein solution, at about 65 DEG C, magnetic stirring apparatus stirs 60min with the speed of 600rpm/min.At normal temperatures and pressures, cooling solution, to room temperature, makes coating solution.Magnetic stirring apparatus is uniformly mixed solution with the speed of 600rpm/min, and pectin is dispersed in solution.Vitamin C tablet is immersed coating solution about 5 seconds, and pour off superfluous solution.Then at room temperature, the thin film wrapping up tablet is obtained after solution evaporation.Repeat film once by the same way, to obtain the thickness of about 150 microns.
Embodiment 2
At normal temperatures and pressures, take 10g zein and be dissolved in 50ml80%(v/v) alcoholic solution in, be stirred to most zein with Glass rod to dissolve, add 7ml oleic acid, it is transparent that constant temperature blender with magnetic force is stirred to dissolution homogeneity with the speed of 600rpm/min.Take 10g pectin, add zein solution, at about 65 DEG C, magnetic stirring apparatus stirs 60min with the speed of 600rpm/min.At normal temperatures and pressures, cooling solution, to room temperature, makes coating solution.Magnetic stirring apparatus is uniformly mixed solution with the speed of 600rpm/min, and pectin is dispersed in solution.Vitamin C tablet is immersed coating solution about 5 seconds, and pour off superfluous solution.Then at room temperature, the thin film wrapping up tablet is obtained after solution evaporation.Repeat film once by the same way, to obtain the thickness of about 150 microns.
Embodiment 3
At normal temperatures and pressures, take 10g zein and be dissolved in 50ml80%(v/v) alcoholic solution in, be stirred to most zein with Glass rod to dissolve, add 7ml oleic acid, it is transparent that constant temperature blender with magnetic force is stirred to dissolution homogeneity with the speed of 600rpm/min.Take 1g pectolysis in 50ml water, it is transparent that constant temperature blender with magnetic force is stirred to dissolution homogeneity with the speed of 600rpm/min.Add 0.5g glycerol, at about 65 DEG C, magnetic stirring apparatus stirs 60min with the speed of 600rpm/min.At normal temperatures and pressures, cooling solution is to room temperature.Vitamin C tablet is immersed pectin solution about 5 seconds, immerses zein solution more about 5 seconds after taking-up, pour off superfluous solution.Then at room temperature, the thin film wrapping up tablet is obtained after solution evaporation.Repeat film once by the same way, to obtain the thickness of about 150 microns.
Comparative example
At normal temperatures and pressures, take 10g zein and be dissolved in 50ml80%(v/v) alcoholic solution in, be stirred to most zein with Glass rod to dissolve, add 7ml oleic acid, it is transparent that constant temperature blender with magnetic force is stirred to dissolution homogeneity with the speed of 600rpm/min.At about 65 DEG C, magnetic stirring apparatus stirs 60min with the speed of 600rpm/min.At normal temperatures and pressures, cooling solution, to room temperature, makes coating solution.Magnetic stirring apparatus is uniformly mixed molten with the speed of 600rpm/min.Vitamin C tablet is immersed coating solution about 5 seconds, and pour off superfluous solution.Then at room temperature, the thin film wrapping up tablet is obtained after solution evaporation.Repeat film once by the same way, to obtain the thickness of about 150 microns.
Drug release is tested
Simulated gastric fluid forms: 0.2%(weight/volume) sodium chloride, 1%(volume/volume) hydrochloric acid (concentration 32%) and 0.7%(weight/volume) pepsin.
Simulation small intestinal solution composition: 0.68%(weight/volume) sodium phosphate, 0.156%(weight/volume) sodium hydroxide and 1%(weight/volume) pancreatinum.
Simulation colon solution composition: 1.3%(weight/volume) potassium phosphate, 0.13%(weight/volume) disodium hydrogen phosphate,anhydrous and 0.3%(volume/volume) pectase.
Test process is as follows:
Simulated solution is slowly stirred down and is cultured to 37 DEG C, at selected time point, get 1ml solution and measure ascorbic content, add 1ml simultaneously and do not ensure the quality of products constant in solution containing the fresh culture of enzyme.Length of testing speech in simulated gastric fluid is 2 hours, then sample is transferred to simulation small intestinal solution.For the zein-pectin tablet being intended to small intestinal release, the testing time in simulation small intestinal solution is 6 hours.For the zein-pectin tablet being intended to colon release, the testing time in simulation small intestinal solution is 4 hours, transfers to afterwards in simulation colon solution and tests 18 hours.
Measuring ascorbic method is: the solution taken out is passed through 0.45 micrometer syringe formula frit, then inject HPLC-DAD system, mobile phase is Milli-Q water/methanol (80:20 volume/volume), and flow velocity remains on 1 ml/min, at room temperature carry out, determined wavelength is 245 nanometers.
As seen from Figure 1, in the vitamin C coating tablet of embodiment 1,2 and comparative example gained, control the release of medicine at different parts by regulating the ratio of pectin and zein.Specifically, in embodiment 2 gained coating tablet (curve 1), mixed solution is adopted to carry out coating, and pectin content is higher, although zein is insoluble to acid solution, but due to the expansion of pectin, membrane structure is destroyed in gastric juice, vitamin C release under one's belt therefore can be realized.And when pectin content is less, as curve 2, medicine release under one's belt can be significantly suppressed.In like manner, due to the difference of zein and pectin content, the rate of release of medicine in intestinal juice also has notable difference, as can be seen here, coated pharmaceutical of the present invention can not only control the release of medicine at different parts, can also control speed and the time of its release, thus makes medicine be more prone to manipulation in the release of human body, be conducive to flexible administration, make it play the best use of.
As seen from Figure 2, in embodiment 3 gained coated tablet, owing to have employed the coating form of film forming respectively, membrane structure is more firm, should not be subject to the impact of gastric juice, intestinal juice effect, can realize the release of human colorectal fixed point.
Although in order to the present invention is described, disclose the preferred embodiments of the invention, but it will be understood by those of skill in the art that when not departing from the design of the present invention and scope that claims limit, various amendment, interpolation and replacement can be made to the present invention.
Claims (13)
1. a coated composition, comprises following composition by weight:
Zein: 1 part;
Pectin: 0.01 ~ 5 part; And
Plasticizer: 0.1 ~ 2 part.
2. coated composition according to claim 1, wherein, described plasticizer be selected from oleic acid, linoleic acid, linolenic acid, stearic acid, glycerol, Polyethylene Glycol, 2,2'-ethylenedioxybis(ethanol). one or more.
3. a coated pharmaceutical preparation, it comprises the coating that coated composition described in solid pharmaceutical preparation and claim 1 or 2 is formed.
4. coated pharmaceutical preparation according to claim 3, wherein, described solid pharmaceutical preparation is the pharmaceutical preparation of stomach and/or colon release administration.
5. the preparation method of coated pharmaceutical preparation described in claim 3 or 4, comprises the following steps:
(1) zein, pectin and plasticizer are dissolved in solvent form coating solution;
(2) solid pharmaceutical preparation is placed in described coating solution and carries out film, volatilize solvent, obtain described coated pharmaceutical preparation.
6. preparation method according to claim 5, wherein, the solvent in described step (1) is aqueous solutions of organic solvent, and the mass ratio of described aqueous solutions of organic solvent and described zein is 1:3 ~ 6; Described organic solvent be selected from ethanol, propanol, isopropyl alcohol, butanediol, amylalcohol, formic acid, acetic acid, lactic acid, acetone one or more.
7. according to the preparation method of claim 5 or 6, wherein, the film-coating procedures of described step (2) is 1 ~ 3 time, and the time of each film is 2 ~ 10 seconds.
8. the preparation method of coated pharmaceutical preparation described in claim 3 or 4, comprises the following steps:
(1) zein and plasticizer are dissolved in solvent form coating solution A, by formation coating solution B soluble in water for pectin;
(2) solid pharmaceutical preparation is placed in successively described coating solution B, coating solution A carries out film, volatilize solvent, obtain described coated pharmaceutical preparation.
9. preparation method according to claim 8, wherein, the solvent in described step (1) is aqueous solutions of organic solvent, and the mass ratio of described aqueous solutions of organic solvent and described zein is 1:3 ~ 6; Described organic solvent be selected from ethanol, propanol, isopropyl alcohol, butanediol, amylalcohol, formic acid, acetic acid, lactic acid, acetone one or more.
10. preparation method according to claim 8, wherein, in described coating solution B, the mass percent concentration of pectin is 1 ~ 5%.
11. preparation methoies according to claim 8, wherein, described coating solution B also comprises the plasticizer that mass percent concentration is 0.1 ~ 1%.
12. preparation methoies according to claim 11, wherein, described plasticizer be selected from oleic acid, linoleic acid, linolenic acid, stearic acid, glycerol, Polyethylene Glycol, 2,2'-ethylenedioxybis(ethanol). one or more.
The preparation method of 13.-12 any one according to Claim 8, wherein, the film-coating procedures of described step (2) is 1 ~ 3 time, and the time of each film is 2 ~ 10 seconds.
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| CN201410130730.3A CN104940946A (en) | 2014-03-28 | 2014-03-28 | Coating composition, coated drug preparation prepared from same and preparation method of coated drug preparation |
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| CN105496982A (en) * | 2015-12-24 | 2016-04-20 | 广东药学院 | Chitosan tablets and preparation method thereof |
| CN107441500A (en) * | 2017-09-19 | 2017-12-08 | 云智前沿科技发展（深圳）有限公司 | Colon targeting drug administration oral formulations film-forming composition and preparation method, application process |
| CN110662427A (en) * | 2017-04-03 | 2020-01-07 | 森馨颜色有限责任公司 | Coating composition, method of making and method of using the same |
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| CN101791298A (en) * | 2009-06-04 | 2010-08-04 | 徐州弘康科技有限公司 | Colon delivery tablet by using pectin / corn protein as coating |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105496982A (en) * | 2015-12-24 | 2016-04-20 | 广东药学院 | Chitosan tablets and preparation method thereof |
| CN105496982B (en) * | 2015-12-24 | 2018-10-19 | 广东药科大学 | A kind of chitosan tablet and preparation method thereof |
| CN110662427A (en) * | 2017-04-03 | 2020-01-07 | 森馨颜色有限责任公司 | Coating composition, method of making and method of using the same |
| CN107441500A (en) * | 2017-09-19 | 2017-12-08 | 云智前沿科技发展（深圳）有限公司 | Colon targeting drug administration oral formulations film-forming composition and preparation method, application process |
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