CN101954086A - Waterborne enteric coating powder as well as preparation and using methods thereof - Google Patents
Waterborne enteric coating powder as well as preparation and using methods thereof Download PDFInfo
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- CN101954086A CN101954086A CN2009103045639A CN200910304563A CN101954086A CN 101954086 A CN101954086 A CN 101954086A CN 2009103045639 A CN2009103045639 A CN 2009103045639A CN 200910304563 A CN200910304563 A CN 200910304563A CN 101954086 A CN101954086 A CN 101954086A
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Abstract
The invention discloses a waterborne enteric coating powder as well as preparation and using methods thereof. The preparation method comprises the following steps of by selecting polyacrylic resin latex as a film forming material, using triethyl citrate and polysorbate-80 as plasticizers and using talcum powder as an antisticking agent, uniformly mixing the polyacrylic resin liquid latex, the triethyl citrate, the polysorbate-80 and the talcum powder, and spraying and drying to obtain the waterborne enteric coating powder. The waterborne enteric coating powder is beneficial to solving the irreconcilable contradiction among water dissolution, moisture resistance and disintegration of coating adjuncts. A coating fluid without layering for a long time can be prepared only by adding a coating agent into water to stir for 25 minutes; the drying temperature needed in the coating process is lower, and therefore, the waterborne enteric coating powder has fewer influence factors on drug effective components and has wide drug component adaptability; and the production cost is low, and the coating time is short. The invention can ensure an enteric film coating procedure to be safe, environmental-protection, high-efficiency and energy-saving.
Description
Technical field
The present invention relates to a kind of drug coating technology and using method, particularly a kind of aqueous enteric coating powder and preparation and using method belong to field of pharmaceutical preparations.
Background technology
The enteric film-coated technique is slower in the development of China, and many pharmacy corporations still exist many problems owing to technical reason on using.Because various supplementary materials that aqueous enteric film coating powder or preparation production aqueous enteric film coating powder are required and coating plant equipment etc., all will be from external import, cost an arm and a leg, enteric film-coated technique production cost height, thus fettered the process that this technology is applied.In recent years, the required material of aqueous enteric film-coated technique is monopolized by overseas enterprise basically, the U.S. blocks the aqueous enteric coating powder Opadry of happy Kanggong department, price is expensive, and (price is: 360 yuan/kg), production technology is also immature, just be easy to generate stifled word, bridging phenomenon as impressed substrate being carried out coating, cause coated tablet appearance poor and non-conformity of quality to close the release regulation of enteric coated preparation.At present, mainly containing for the powder filmogen domestic production of aqueous enteric coating: Hydroxypropyl Methylcellulose Phathalate (HPMCP), succinic acid hydroxypropylmethylcellulose acetate methylcellulose (HPMCAS), polyacrylic acid resin emulsion (polyacrylic resin I number) etc.; External mainly containing of producing: the Youteqi L-30D-55 colloidal sol that German Romo Co.,Ltd produces, the happy Kanggong agency's of department of Shanghai card Opadry etc.It is the alcohol enteric coating powder of solvent that the enteric coatel tablets of domestic production at present are with ethanol, and pure dissolubility enteric coating powder is owing to use ethanol as solvent, deposits inflammable, explosive danger because of alcoholic acid, volatile, so surrounding is had certain influence; And aqueous enteric coating powder only is an imported product, and price is more expensive.Therefore, seem for the development of aqueous enteric coating powder and be even more important.
Summary of the invention
The objective of the invention is to overcome defective of the prior art: aqueous enteric coating powder and preparation and using method that the release regulation that a kind of cost is low, the coated tablet quality meets enteric coated preparation is provided.
The objective of the invention is to be achieved through the following technical solutions:
Select for use polyacrylic acid resin emulsion as filmogen, triethyl citrate, Tween-80 are made plasticizer; Pulvis Talci is made antiplastering aid and is made.
Concrete it is to use polyacrylic acid resin emulsion 35.0kg, Tween-80 3.5kg, and triethyl citrate 2.63kg, Pulvis Talci 1.75kg makes.
The preparation method of aqueous enteric coating powder is with polyacrylic acid resin emulsion 35.0kg; Tween-80 3.5kg; Triethyl citrate 2.63kg; Pulvis Talci 1.75kg mix homogeneously, spray drying (unit type: promptly get aqueous enteric coating powder the GLZ-00 spray drying tower).
A kind of method that makes use enteric coating powder, it uses step to be:
The preparation of A, aqueous enteric coating liquid: water intaking property enteric coating powder, be dissolved in purified water, stir, formation aqueous enteric coating liquid (solid content is: 8.8%), concrete operations are as follows:
(1) add the good purified water of calculating in joining the solution device, the liquid level of purified water is preferably roughly the same with the diameter of molten device;
(2) agitator is stretched into 2/3 place under the liquid level (stirrer diameter should be container diameter 1/3);
(3) start agitator, mixing speed should make the liquid in the container be stirred fully, and liquid level just forms whirlpool and is advisable;
(4) aqueous enteric coating powder constantly is sprinkling upon (adding speed should be whipped into the Black Warrior rapidly with coating powder and be advisable, and adding coating powder should finish) on the whirlpool liquid level with speed stably in several minutes;
(5) add coating powder and finish after, mixing speed slowed down whirlpool is just disappeared, continue to stir and disperseed fully to coating powder in 45 minutes;
The screening of B, aqueous enteric coating powder art for coating parameter and definite: 4～6 hours coating time; The coating pan rotating speed is (before 1 hour: 2r/min; Finish until coating after 1 hour: 3r/min); 75 ℃ of inlet temperature; 49 ℃～52 ℃ of leaving air temps; Air pressure (4.0～5.0kg/cm
3); Rifle and sheet bed distance (25cm-3cm); Shower nozzle discharge rate (spray speed: 0.16kg/min before 1 hour; Spray speed after 1 hour: 0.22kg/min); Dry in the air 1 hour sheet time;
The coating of C, aqueous enteric coating powder: substrate is put into coating pan starts, be preheated to 40 ℃ at a slow speed, reach temperature back spray gun and aim at and turn over sheet bed 1/3 place that falls and carry out that spray coating is not open close goes into hot blast, spray speed to keep unilateral moistening but adhesion for well.(coating increases weight 4%～6%) continued logical hot blast after hydrojet finished, and turned down rotating speed dry 30 minutes, stopped to heat, and the sheet that dries in the air is got sheet to the room temperature shutdown and put into the square position, 24 hours pick test of natural air drying.
Water of the present invention replaces organic solvent (ethanol), aqueous enteric coating powder prescription is screened, and finally determine optimization formula; The technical study and the quality research of aqueous enteric coating powder have been carried out, and the study on the stability of aqueous enteric coating powder and the formulation of quality standard have been carried out, carry out coating with aqueous enteric coating powder of the present invention, make the ECT outward appearance of production good, steady quality and meet enteric coatel tablets rules of preparations (Chinese Pharmacopoeia version appendix in 2005 I A) and the regulation of enteric coated preparation drug release determination method (Chinese Pharmacopoeia version appendix in 2005 X D).
The present invention by medicine is carried out enteric coated can lucifuge, moistureproof and air-isolation is with the increase stability of drug; Cover the disagreeable taste of medicine, facilitate patients; The release position and the rate of release of control medicine; The compatibility that prevents medicine changes; Improve the mode of appearance of tablet etc.Advantages such as it is few also to have operation, and the time is short, and energy consumption is low, and the tablet weightening finish is few.Usually contain high molecular polymer (filmogen) in the prescription of coating solution, plasticizer, stain, solvent etc.Cooperate the development of pharmaceutical equipment, aqueous enteric coating technology can be appeared the big production of industrialization suddenly, and satisfy the requirement of modern GMP fully, so adopt aqueous enteric coating technology to become a general development direction of preparation factory to pharmaceutical production equipment and production environment.Make use enteric coating powder carry out the trend that enteric coating is development, aqueous enteric coating powder is to use ethanol as solvent for overcoming alcohol enteric coating powder, and ethanol is volatile; The alcohol enteric coating liquid has inflammable, explosive danger and surrounding is produced the shortcoming of pollution effect, and the advantage of developing it grows up.High-quality aqueous enteric coating powder industrialization prospect: the 1. industrialization production of aqueous enteric coating powder, from raw material enter factory, intermediate products all have analytical control to finished product step by step, reach standard and just can enter next step, dispatch from the factory until finished product, this is just avoided the contingent various quality problems of import aqueous enteric coating powder to greatest extent, thereby thereby reaches the stable stay-in-grade purpose of coated tablet of aqueous enteric coating opaque amount.2. aqueous enteric coating powder only needs to have saved the productive labor time with purified water dissolving, homogenize coating immediately, uses very convenient.3. now be mixed with suspension before the aqueous enteric coating powder coating, phenomenon such as can avoid the incidental oxidation of preparation overnight, layering, precipitation, pollute, go mouldy.4. superior in quality aqueous enteric coating powder has a good guarantee to coating quality.5. coating cost people can prepare, and need not to join in addition the special messenger.Like this, economize the people, save time, province's equipment, so calculate a lot of costs of comparable pure dissolubility coating powder saving by total ratio of performance to price.
The aqueous enteric coating powder of the present invention exploitation has successfully solved the contradiction that is difficult to be in harmonious proportion between water-soluble, moistureproof, the disintegrate three of coating adjuvant, stirs 25 minutes as long as coating materials is added in the water, just can be made into homogeneous, and not stratified coating solution for a long time; The required baking temperature of coating process is lower, and the influence factor is less to effective ingredient, has ingredient adaptability widely; Equipment cleans easily; Production cost is low and the coating time is short.Like this, succeeding in developing of aqueous enteric coating powder can make enteric film coating operation reach safety, environmental protection, efficient, energy-conservation.Really bring huge economic benefit and social benefit for enterprise.
The specific embodiment
Embodiment 1:
Select polyacrylic acid resin emulsion 35.0kg for use, Tween-80 3.5kg, triethyl citrate 2.63kg, Pulvis Talci 1.75kg mix homogeneously, spray drying (unit type: promptly get aqueous enteric coating powder the GLZ-00 spray drying tower).
The using method of aqueous enteric coating powder, it uses step to be:
The preparation of A, aqueous enteric coating liquid: water intaking property enteric coating powder, be dissolved in purified water, stir, formation aqueous enteric coating liquid (solid content is: 8.8%), concrete operations are as follows:
(1) add the good purified water of calculating in joining the solution device, the liquid level of purified water is preferably roughly the same with the diameter of molten device;
(2) agitator is stretched into 2/3 place under the liquid level (stirrer diameter should be container diameter 1/3);
(3) start agitator, mixing speed should make the liquid in the container be stirred fully, and liquid level just forms whirlpool and is advisable;
(4) aqueous enteric coating powder constantly is sprinkling upon (adding speed should be whipped into the Black Warrior rapidly with coating powder and be advisable, and adding coating powder should finish) on the whirlpool liquid level with speed stably in several minutes;
(5) add coating powder and finish after, mixing speed slowed down whirlpool is just disappeared, continue to stir and disperseed fully to coating powder in 45 minutes;
The screening of B, aqueous enteric coating powder art for coating parameter and definite: 4～6 hours coating time; The coating pan rotating speed is (before 1 hour: 2r/min; Finish until coating after 1 hour: 3r/min); 75 ℃ of inlet temperature; 49 ℃～52 ℃ of leaving air temps; Air pressure (4.0～5.0kg/cm
3); Rifle and sheet bed distance (25cm-3cm); Shower nozzle discharge rate (spray speed: 0.16kg/min before 1 hour; Spray speed after 1 hour: 0.22kg/min); Dry in the air 1 hour sheet time;
The coating of C, aqueous enteric coating powder: substrate is put into coating pan starts, be preheated to 40 ℃ at a slow speed, reach temperature back spray gun and aim at and turn over sheet bed 1/3 place that falls and carry out that spray coating is not open close goes into hot blast, spray speed to keep unilateral moistening but adhesion for well.(coating increases weight 4%～6%) continued logical hot blast after hydrojet finished, and turned down rotating speed dry 30 minutes, stopped to heat, and the sheet that dries in the air is got sheet to the room temperature shutdown and put into the square position, 24 hours pick test of natural air drying.
Claims (4)
1. aqueous enteric coating powder, it is characterized in that: select for use polyacrylic acid resin emulsion as filmogen, triethyl citrate, Tween-80 are made plasticizer; Pulvis Talci is made antiplastering aid and is made.
2. a kind of aqueous enteric coating powder according to claim 1 is characterized in that: it is to use polyacrylic acid resin emulsion 35.0kg, Tween-80 3.5kg, and triethyl citrate 2.63kg, Pulvis Talci 1.75kg makes.
3. the preparation method of an aqueous enteric coating powder is characterized in that: with polyacrylic acid resin emulsion 35.0kg, and Tween-80 3.5kg, triethyl citrate 2.63kg, Pulvis Talci 1.75kg mix homogeneously promptly gets aqueous enteric coating powder after the spray drying.
4. method of using the described aqueous enteric coating of claim 1 to 3 powder is characterized in that: it uses step to be:
The preparation of A, aqueous enteric coating liquid: water intaking property enteric coating powder, be dissolved in purified water, stir, form the aqueous enteric coating liquid, concrete operations are as follows:
(1) add the good purified water of calculating in joining the solution device, the liquid level of purified water is preferably roughly the same with the diameter of molten device;
(2) agitator is stretched into 2/3 place under the liquid level;
(3) start agitator, mixing speed should make the liquid in the container be stirred fully, and liquid level just forms whirlpool and is advisable;
(4) aqueous enteric coating powder constantly is sprinkling upon on the whirlpool liquid level with speed stably;
(5) add coating powder and finish after, mixing speed slowed down whirlpool is just disappeared, continue to stir and disperseed fully to coating powder in 45 minutes;
The screening of B, aqueous enteric coating powder art for coating parameter and definite: 4～6 hours coating time; The coating pan rotating speed is (before 1 hour: 2r/min; Finish until coating after 1 hour: 3r/min); 75 ℃ of inlet temperature; 49 ℃～52 ℃ of leaving air temps; Air pressure (4.0～5.0kg/cm3); Rifle and sheet bed distance (25cm-3cm); Shower nozzle discharge rate (spray speed: 0.16kg/min before 1 hour; Spray speed after 1 hour: 0.22kg/min); Dry in the air 1 hour sheet time;
The coating of C, aqueous enteric coating powder: substrate is put into coating pan start; be preheated to 40 ℃ at a slow speed; spray gun is aimed at and to be turned over sheet bed 1/3 place that falls and carry out that spray coating is not open close goes into hot blast behind the Da Wen; spray speed to keep unilateral moistening but adhesion for well; continue logical hot blast after hydrojet finishes, turned down rotating speed dry 30 minutes, stop heating; the sheet that dries in the air is got sheet to the room temperature shutdown and is put into the square position, 24 hours pick test of natural air drying.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009103045639A CN101954086A (en) | 2009-07-20 | 2009-07-20 | Waterborne enteric coating powder as well as preparation and using methods thereof |
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| CN2009103045639A CN101954086A (en) | 2009-07-20 | 2009-07-20 | Waterborne enteric coating powder as well as preparation and using methods thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103143025A (en) * | 2013-04-07 | 2013-06-12 | 贵州圣济堂制药有限公司 | Water-soluble enteric coating powder as well as preparation method and use method thereof |
| CN104784048A (en) * | 2014-01-16 | 2015-07-22 | 南京瑞尔医药有限公司 | Method for preparing bromelain enteric coatel tablets |
| CN103920156B (en) * | 2014-04-04 | 2016-06-01 | 成都科特包衣技术有限公司 | A kind of oral administration enteron aisle positioning release medicine film-coating premixing auxiliary material and its preparation method |
-
2009
- 2009-07-20 CN CN2009103045639A patent/CN101954086A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103143025A (en) * | 2013-04-07 | 2013-06-12 | 贵州圣济堂制药有限公司 | Water-soluble enteric coating powder as well as preparation method and use method thereof |
| CN104784048A (en) * | 2014-01-16 | 2015-07-22 | 南京瑞尔医药有限公司 | Method for preparing bromelain enteric coatel tablets |
| CN103920156B (en) * | 2014-04-04 | 2016-06-01 | 成都科特包衣技术有限公司 | A kind of oral administration enteron aisle positioning release medicine film-coating premixing auxiliary material and its preparation method |
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Application publication date: 20110126 |