CN104258410A - Novel enteric film coating agent containing hydroxypropyl methyl acetate succinate - Google Patents
Novel enteric film coating agent containing hydroxypropyl methyl acetate succinate Download PDFInfo
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- CN104258410A CN104258410A CN201410455593.0A CN201410455593A CN104258410A CN 104258410 A CN104258410 A CN 104258410A CN 201410455593 A CN201410455593 A CN 201410455593A CN 104258410 A CN104258410 A CN 104258410A
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- hydroxypropyl methyl
- methyl cellulose
- aqueous dispersion
- cellulose phthalate
- stabilizing agent
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Abstract
The invention belongs to the technical field of pharmaceutical production, relates to a novel enteric film coating material used in a preparation process of a medicine solid preparation, and provides a hydroxypropyl methyl cellulose acetate succinate aqueous dispersion which does not contain an organic solvent and is friendly to environment, and a preparation method of the hydroxypropyl methyl cellulose acetate succinate aqueous dispersion. The hydroxypropyl methyl cellulose acetate succinate aqueous dispersion can be applied to the procedures such as pelletizing and coating of the solid medicine preparation; the functionality of enteric drugs is improved; the preparation method is simple and convenient to operate, and is universally applicable to existing pharmaceutical equipment; and high temperature and high pressure are not used.
Description
Technical field
The invention belongs to pharmaceutical production technical field, relating to a kind of new enteric-coating material for using in pharmaceutical solid preparation production process.
Background technology
Hydroxypropyl Methyl Cellulose Phthalate (hydmxypmpylmethyl cellulose acetate succinate, HPMCAS) is acetic acid and the succinic acid mixed ester of hypromellose, is the enteric-coating material developed in recent years.
Hydroxypropyl Methyl Cellulose Phthalate, has good filming performance, may be used for the coating of tablet in pharmaceutical production, micropill, granule and powder, is a kind of new adjuvant in medicament enteric-coated formulation.Because Hydroxypropyl Methyl Cellulose Phthalate is water insoluble, during preparation coating solution, often with an organic solvent dosing, therefore causes the explosion-proof particular/special requirement to equipment, the pollution to environment and the organic solvent problem such as residual in the formulation.
Therefore an urgent demand up to now improves the using method of Hydroxypropyl Methyl Cellulose Phthalate, and has proposed not containing organic solvent, environment amenable ethyl cellulose type of service.
Summary of the invention
In order to solve problems of the prior art, the invention provides one not containing organic solvent, environment amenable Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion and preparation method thereof.
In order to realize object of the present invention, the technical scheme of employing is summarized as follows:
A kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion, it is characterized in that, described aqueous dispersion contains Hydroxypropyl Methyl Cellulose Phthalate, stabilizing agent and water, wherein, water is the continuous phase in aqueous dispersion, Hydroxypropyl Methyl Cellulose Phthalate is distributed in water uniformly, stabilizing agent be in aqueous dispersion except Hydroxypropyl Methyl Cellulose Phthalate and water, energy Dichlorodiphenyl Acetate hypromellose succinate plays the general name of a class material of Stabilization, and it can make Hydroxypropyl Methyl Cellulose Phthalate be uniformly distributed.
Described a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion, it is characterized in that, described stabilizing agent is one or more in following material: esters nonionic surfactant, Sulfates anion surfactant, Sulfonates anion surfactant, carbon number is the linear and branched carboxylic acids of 2 ~ 20, and carbon number is the linear and branched fatty alcohol of 2 ~ 20.Wherein said esters nonionic surfactant is preferably one or more in polyoxyethylene oleic acid ester, polyoxyethylene stearic acid ester, span, tween and polyoxyethylene castor oil; Described sulphate anion surface active agent is preferably sodium lauryl sulphate; Described Sulfonates anion surfactant is preferably one or more in dodecylbenzene sodium sulfonate, sodium butylnaphthalenesulfonate and petroleum sodium sulfonate; Described carbon number is the linear and branched carboxylic acids of 2 ~ 20, one or more preferably in oleic acid, linolenic acid, linoleic acid, and the oils containing this type of carboxylic acid composition, as one or more in Oleum Cocois, Oleum Ricini, Oleum Gossypii semen Flos Carthami oil; Described carbon number is the linear and branched fatty alcohol of 2 ~ 20, is preferably cetyl alcohol, just octadecanol, tertiary hexadecanol and tertiary octadecanol one or more.
Described a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion, is characterized in that, the content of described stabilizing agent is preferably 0.5 ~ 20% of aqueous dispersion quality.
Described a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion, is characterized in that, the content of described Hydroxypropyl Methyl Cellulose Phthalate is preferably 1 ~ 20% of moisture, and better is 1 ~ 7%.
Described a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion, is characterized in that, the grain size of micropowder of described Hydroxypropyl Methyl Cellulose Phthalate is 0.5 ~ 5 μm.
Described a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion, it is characterized in that, also can contain in acidity regulator, defoamer and plasticizer one or more, acidity regulator is the regulator that this area routine uses, and is preferably one or more in hydrochloric acid, sodium hydroxide, potassium hydroxide, ammonia, sodium bicarbonate and sodium carbonate; Described defoamer is the defoamer that this area routine uses, and is preferably one or more in dimethicone, fluorosilicone, ethylene glycol siloxanes, ethylenedistearamide, distearyl decamethylene diamine and Pluronic F68; Described plasticizer is the plasticizer that this area routine uses, and is preferably one or more in diethyl phthalate, dibutyl phthalate, triethyl citrate, dibutyl sebacate and acetylation monoglyceride etc.
Described a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion, it is characterized in that, preparation method is:
(1) Hydroxypropyl Methyl Cellulose Phthalate, stabilizing agent are mixed with solvent, obtain mixed liquor A, preferably, in mixed liquor A, can also plasticizer be contained;
(2) stabilizing agent is mixed with solvent, obtain mixed liquid B, preferably can also contain acidity regulator in mixed liquid B;
(3), by mixed liquor A and B mixing, remove organic solvent after emulsification pretreatment, obtain Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion, emulsification pretreatment rotating speed is preferably 1000 ~ 30000rpm, can also carry out stirring and make the thick emulsifying of mixed liquor before carrying out emulsifying shearing;
(4) defoamer can be added in first three step process.
Compared with prior art, the good effect that the present invention has is: Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion of the present invention is containing organic solvent, environmentally friendly, can be used for granulation and the coating supervisor of solid pharmaceutical preparation, improve enteric agents functional, and preparation method is easy and simple to handle, do not use High Temperature High Pressure, be generally suitable for existing pharmaceutical equipment.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is described further.
Example 1
(1) mixed liquor A: 70 gram particle footpaths are less than the Hydroxypropyl Methyl Cellulose Phthalate micropowder of 5 μm, 80 grams of dichloromethane and 5 grams of hexadecanol, mixing makes dissolving.
(2) mixed liquid B: 6 grams of sodium lauryl sulphates are dissolved in the water of 800 grams.
(3) be placed in homogenizer by mixed liquor A and B mixing, stir the thick breast of emulsifying in 10 minutes with the rotating speed of 50rpm, thick breast is placed in high-speed shearing emulsion machine, 8000rpm rotating speed emulsifying 0.5 hour, obtains homogeneous microemulsion.Be placed in by homogeneous microemulsion in the distilling under reduced pressure container of belt stirrer, 80 degree of distilling under reduced pressure, to organic solvent all steams, solid content is adjusted to about 7%, to obtain final product.
Example 2
(1) mixed liquor A: Hydroxypropyl Methyl Cellulose Phthalate micropowder, 20 grams of triethyl citrates, 200 grams of ethyl acetate and 5 grams of hexadecanol that 50 gram particle footpaths are less than 5 μm, mixing makes dissolving.
(2) mixed liquid B: 6 grams of sodium lauryl sulphates are dissolved in the water of 200 grams.
(3) be placed in homogenizer by mixed liquor A and B mixing, stir the thick breast of emulsifying in 10 minutes with the rotating speed of 50rpm, thick breast is placed in high-speed shearing emulsion machine, 3000rpm rotating speed emulsifying 1 hour, obtains homogeneous microemulsion.Be placed in by homogeneous microemulsion in the distilling under reduced pressure container of belt stirrer, 50 degree of distilling under reduced pressure, to organic solvent all steams, solid content is adjusted to about 5%, to obtain final product.
Example 3
(1) mixed liquor A: Hydroxypropyl Methyl Cellulose Phthalate micropowder and 100 grams of dichloromethane that 70 gram particle footpaths are less than 5 μm, mixing makes dissolving.
(2) mixed liquid B: 10 grams of Tween 80s are dissolved in the water of 200 grams.
(3) be placed in homogenizer by mixed liquor A and B mixing, add 5 grams of cetyl alcohol, stir the thick breast of emulsifying in 10 minutes, thick breast is placed in high-speed shearing emulsion machine with the rotating speed of 50rpm, 1000rpm rotating speed emulsifying 1 hour, obtains homogeneous microemulsion.Be placed in by homogeneous microemulsion in the distilling under reduced pressure container of belt stirrer, 60 degree of distilling under reduced pressure, to organic solvent all steams, solid content is adjusted to about 6%, to obtain final product.
Exemplary scenario described here is only the explanation to the principle of the invention, and preferred embodiment of the present invention, should not by any way, utilizes describing and limit the scope of the invention above.The professional person of this area, can utilize principle of the present invention, designs various different embodiment, and does not exceed scope of the present invention.
Claims (8)
1. a Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion, it is characterized in that, described aqueous dispersion contains Hydroxypropyl Methyl Cellulose Phthalate, stabilizing agent and water, wherein, water is the continuous phase in aqueous dispersion, Hydroxypropyl Methyl Cellulose Phthalate is distributed in water uniformly, stabilizing agent be in aqueous dispersion except Hydroxypropyl Methyl Cellulose Phthalate and water, energy Dichlorodiphenyl Acetate hypromellose succinate plays the general name of a class material of Stabilization, and it can make Hydroxypropyl Methyl Cellulose Phthalate be uniformly distributed.
2. a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion as claimed in claim 1, is characterized in that, the content of described Hydroxypropyl Methyl Cellulose Phthalate is 1 ~ 20% of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion.
3. a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion as claimed in claim 1, is characterized in that, the grain size of micropowder of described Hydroxypropyl Methyl Cellulose Phthalate is 0.5 ~ 5 μm.
4. a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion as claimed in claim 1, it is characterized in that, described stabilizing agent is one or more in following material: esters nonionic surfactant, Sulfates anion surfactant, Sulfonates anion surfactant, carbon number is the linear and branched carboxylic acids of 2 ~ 20, and carbon number is the linear and branched fatty alcohol of 2 ~ 20.
5. a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion as claimed in claim 4, it is characterized in that, described esters nonionic surfactant is one or more in polyoxyethylene oleic acid ester, polyoxyethylene stearic acid ester, span, tween and polyoxyethylene castor oil; Described sulphate anion surface active agent is sodium lauryl sulphate; Described Sulfonates anion surfactant is one or more in dodecylbenzene sodium sulfonate, sodium butylnaphthalenesulfonate and petroleum sodium sulfonate; Described carbon number be 2 ~ 20 linear and branched carboxylic acids be one or more in oleic acid, linolenic acid, linoleic acid, and contain the oils of this type of carboxylic acid composition, as one or more in Oleum Cocois, Oleum Ricini, Oleum Gossypii semen Flos Carthami oil; Described carbon number is the linear and branched fatty alcohol of 2 ~ 20, is one or more of cetyl alcohol, just octadecanol, tertiary hexadecanol and tertiary octadecanol.
6. a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion as claimed in claim 1, is characterized in that, the content of described stabilizing agent is 0.5 ~ 20% of aqueous dispersion quality.
7. a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion as claimed in claim 1, it is characterized in that, also containing one or more in acidity regulator, defoamer and plasticizer, acidity regulator is the regulator that this area routine uses, and is one or more in hydrochloric acid, sodium hydroxide, potassium hydroxide, ammonia, sodium bicarbonate and sodium carbonate; Described defoamer is the defoamer that this area routine uses, and is one or more in dimethicone, fluorosilicone, ethylene glycol siloxanes, ethylenedistearamide, distearyl decamethylene diamine and Pluronic F68; Described plasticizer is the plasticizer that this area routine uses, and is one or more in diethyl phthalate, dibutyl phthalate, triethyl citrate, dibutyl sebacate and acetylation monoglyceride etc.
8. a kind of Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion as claimed in claim 1, it is characterized in that, preparation method is:
(1) Hydroxypropyl Methyl Cellulose Phthalate, stabilizing agent are mixed with solvent, obtain mixed liquor A, preferably, in mixed liquor A, can also plasticizer be contained;
(2) stabilizing agent is mixed with solvent, obtain mixed liquid B, preferably can also contain acidity regulator in mixed liquid B;
(3), by mixed liquor A and B mixing, remove organic solvent after emulsification pretreatment, obtain Hydroxypropyl Methyl Cellulose Phthalate aqueous dispersion, emulsification pretreatment rotating speed is preferably 1000 ~ 30000rpm, can also carry out stirring and make the thick emulsifying of mixed liquor before carrying out emulsifying shearing.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410455593.0A CN104258410A (en) | 2014-09-10 | 2014-09-10 | Novel enteric film coating agent containing hydroxypropyl methyl acetate succinate |
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| CN201410455593.0A CN104258410A (en) | 2014-09-10 | 2014-09-10 | Novel enteric film coating agent containing hydroxypropyl methyl acetate succinate |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6169130B1 (en) * | 1998-05-24 | 2001-01-02 | Roland Bodmeier | Method for improving the dispersion of redispersible polymer powders |
| CN101088494A (en) * | 2006-06-16 | 2007-12-19 | 信越化学工业株式会社 | Enteric coated granule and method for preparing the same |
| CN103405776A (en) * | 2013-08-28 | 2013-11-27 | 天津爱勒易医药材料有限公司 | Water-soluble coating powder and preparation method thereof |
-
2014
- 2014-09-10 CN CN201410455593.0A patent/CN104258410A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6169130B1 (en) * | 1998-05-24 | 2001-01-02 | Roland Bodmeier | Method for improving the dispersion of redispersible polymer powders |
| CN101088494A (en) * | 2006-06-16 | 2007-12-19 | 信越化学工业株式会社 | Enteric coated granule and method for preparing the same |
| CN103405776A (en) * | 2013-08-28 | 2013-11-27 | 天津爱勒易医药材料有限公司 | Water-soluble coating powder and preparation method thereof |
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Application publication date: 20150107 |