CN101239051A - Erythromycin enteric-coated capsule and preparation thereof - Google Patents
Erythromycin enteric-coated capsule and preparation thereof Download PDFInfo
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- CN101239051A CN101239051A CNA2008100694676A CN200810069467A CN101239051A CN 101239051 A CN101239051 A CN 101239051A CN A2008100694676 A CNA2008100694676 A CN A2008100694676A CN 200810069467 A CN200810069467 A CN 200810069467A CN 101239051 A CN101239051 A CN 101239051A
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Abstract
The invention provides an erythromycin enteric-coated capsule and the preparation method. The invention is characterized in that: the component ratio of the enteric-coated liquid of the enteric-pellets capsules contained in the enteric-coated capsules counted by weight percentage is that: polyacrylic resin: II: 1, diethyl phthalate: 0.07 to 0.1, Tween-80:0.08 to 0.12, castor oil: 0.08 to 0.12, ethanol whose concentration is bigger than or equal to 95%: 12 to 14; all are counted as weight percentage. The invention conquers defects in the prior art, elevates the product quality, keeps the releasing degree of the product stable and guarantees the quality as well as healing effect of the product during the period of validity, and also the preparation is simple and convenient, the work efficiency is high and the quality of the products is quite well.
Description
Technical field
The present invention relates to a kind of erythromycin enteric-coated capsule and preparation method thereof.
Background technology
Erythromycin enteric-coated capsule belongs to the antibiotics medicine, and principal indication has 1. as the alternative medication of infection such as penicillin anaphylaxis patient treatment Hemolytic streptococcus, streptococcus pneumoniae; 2. l; 3. mycoplasma pneumoniae pneumonia; 4. Chlamydia pneumoniae pneumonia; 5. oral cavity infection due to urogenital infections, chlamydia trachomatis conjunctivitis, gonococcal infection, the anaerobe, campylobacter jejuni enteritis, pertussis etc. due to other chlamydiaceaes, the Mycoplasma.Because erythromycin is bigger to gastrointestinal stimulation, existing erythromycin capsule agent content adopts enteric coated micropill, and is promptly enteric coated on micropill, discharges under one's belt to stop erythromycin, makes it just reach therapeutic purposes by discharging rapidly in small intestinal.The quality standard that this product adopts is WS-1001-(HD-0423)-2002.Require this product in acid, (be equivalent to gastric juice) 2 hours release≤10%, 1 hour release 〉=85% in buffer (being equivalent to intestinal juice) in the quality standard.Yet erythromycin enteric-coated capsule release instability in the market, in storage process, release reduces gradually, thereby can't guarantee that this product is qualified before the deadline, has had a strong impact on the quality and the curative effect of this product.Trace it to its cause mainly is because the main component cellulose acetate-phthalate in the enteric coating liquid proportioning of the enteric coated micropill that existing erythromycin enteric-coated capsule includes contains unsaturated ester bond and alkyl, unsaturated group dissociates out easily in storage process, causes release to reduce.
Summary of the invention
Purpose of the present invention just is to provide a kind of release stable, can guarantee its quality and curative effect before the deadline, erythromycin enteric-coated capsule.
Another object of the present invention provides the preparation method of this erythromycin enteric-coated capsule, and this method technology is easy, work efficiency is high, the good product quality that obtains.。
The object of the present invention is achieved like this: a kind of erythromycin enteric-coated capsule, it includes enteric coated micropill, the enteric coating liquid set of dispense that it is characterized in that above-mentioned enteric coated micropill is than being polyacrylic resin II:1, diethyl phthalate: 0.07～0.1, soil temperature-80:0.08～0.12, Oleum Ricini: 0.08～0.12, concentration is more than or equal to 95% ethanol: 12～14; All by weight.
Another object of the present invention is the preparation method of above-mentioned erythromycin enteric-coated capsule, and it may further comprise the steps:
A, by above-mentioned enteric coating liquid set of dispense ratio, wherein polyacrylic resin II is dissolved in the ethanol of said ratio, and then add remaining ingredient in the proportioning stir and dissolve after enteric coating liquid is standby;
B, will containing the erythromycin raw material for the treatment of effective dose and mixing acceptable accessories, to make the erythromycin micropill standby;
C, above-mentioned erythromycin micropill is carried out enteric coating: be about to above-mentioned erythromycin micropill and place the coating pelletizing machine; start the coating pelletizing machine; and the above-mentioned enteric coating liquid for preparing evenly be sprayed on erythromycin micropill surface by spray gun promptly get erythromycin enteric micropill, incapsulate product.
For the ease of implementing enteric coating technology, the erythromycin micropill particle diameter of making in the above-mentioned b step is 0.6～0.8 millimeter.
The enteric coating rate of body weight gain of the erythromycin enteric micropill that obtains in the above-mentioned c step is 12%～18%.
Coating pelletizing machine in the above-mentioned c step is a BZJ-1000F II type coating pelletizing machine, and its rotating speed is 40～60 rev/mins in the coating process.
In order to improve the quality of product of the present invention, make it obtain the uniform enteric coated micropill of enteric coat layer, the spray gun power in the above-mentioned c step is gear pump, its rotating speed is 30～40 rev/mins in the coating process.
In order to improve the enteric coating work efficiency; so that the enteric coated micropill behind the coating can be in time, be dried equably; in the enteric coating process in the above-mentioned c step; except the bottom of coating pelletizing machine has 1 air-blast device; above the coating pelletizing machine or also have additional 2～3 air-blast devices all around, and when starting the coating pelletizing machine, open all air-blast devices.
The invention has the beneficial effects as follows: (1) product of the present invention is through measuring, and its release is stable, and promptly in storage process, release changes very little.Its main cause is owing to enteric coating liquid proportioning main component among the present invention has substituted cellulose acetate-phthalate with polyacrylic resin II, and polyacrylic resin II is stable, in storage process, can not produce free group, thereby guarantee that product of the present invention is qualified before the deadline, its quality and curative effect are unaffected.The release of product of the present invention and erythromycin enteric-coated capsule product of the prior art relatively sees Table 1 and table 2.
Table 1: the release testing result of erythromycin enteric-coated capsule product in the prior art
Table 2: the release testing result of product of the present invention
Table 1 result shows, the erythromycin enteric-coated capsule product that prior art is produced, and in storage process, the release that (is equivalent to gastric juice) in the acid is along with the prolongation of time, and release raises gradually; Release then reduces gradually in buffer (being equivalent to intestinal juice), thereby can't guarantee that this product is qualified before the deadline.And table 2 result shows, the erythromycin enteric-coated capsule product among the present invention is in storage process, in the acid in release and the buffer release along with the prolongation of time, dissolution does not have significant change, thereby guarantees that product of the present invention is qualified before the deadline, and its quality and curative effect are unaffected.(2) because enteric coating liquid proportioning main component of the prior art is a cellulose acetate-phthalate, and it belongs to the extremely strong material of close ester, so the partial solvent in the enteric coating liquid proportioning is an acetone, acetone belongs to inflammable explosive article, has potential safety hazard; This solvent volatility is extremely strong in addition, stimulates greatly, carries out coating with this solvent, and solvent volatilizees easily in operating process, causes coating the second half solids concentration to increase hydrojet difficulty, coatings heterogeneity.And enteric coating liquid proportioning main component is polyacrylic resin II among the present invention, and the diethyl phthalate in the proportioning belongs to the hydrophilic dual polarity product of close ester, so whole solvents are ethanol in the enteric coating liquid proportioning, both fundamentally solved inflammable and explosive security hidden trouble, use ethanol as solvent simultaneously, solvent evaporates slows down in operating process, and solids concentration is stable in the coating process, has guaranteed the uniformity of coatings.(3) abandoned the available technology adopting peristaltic pump in the preparation method of the present invention as spray gun power, used gear pump instead as spray gun power, avoided the pulse phenomenon in the former spray gun work, it is more even to reach coatings, has further improved the quality of product of the present invention.(4) in the preparation method of the present invention; for make enteric coated micropill in the coating process can be in time, be dried equably; improve the enteric coating work efficiency; the present invention is above the coating pelletizing machine or increased by 2～3 air-blast devices all around; there is 1 air-blast device relatively with the bottom that in the prior art is the coating pelletizing machine, improved coating speed greatly.In the prior art, generally producing the 10kg coated pill needs 16～17 hours, and only needs 3～4 hours among the present invention, improves 4～5 times of work efficiency.
In a word, product of the present invention and preparation method that the inventor obtains through a large amount of practices, many defectives of the prior art have been overcome, not only improved the product quality of product of the present invention, make its product release of the present invention stable, guaranteed product of the present invention quality and curative effect before the deadline, and preparation technology is easy, work efficiency height and the good product quality that obtains.
The specific embodiment
Mode below by embodiment further specifies the present invention, does not therefore limit the present invention among the described scope of embodiments.
Embodiment 1
A kind of erythromycin enteric-coated capsule, wherein the enteric coating liquid set of dispense of enteric coated micropill is counted than by weight: polyacrylic resin II:1, and diethyl phthalate: 0.07, soil temperature-80:0.08, Oleum Ricini: 0.08, concentration is more than or equal to 95% ethanol: 12.
Its preparation method is according to the following steps:
A, by above-mentioned enteric coating liquid set of dispense ratio, wherein polyacrylic resin II is dissolved in the ethanol of said ratio, and then add remaining ingredient in the proportioning stir and dissolve after enteric coating liquid is standby;
B, will containing the erythromycin raw material for the treatment of effective dose and sucrose, to be mixed and made into particle diameter be that 0.6～0.8 millimeter erythromycin micropill is standby;
C, above-mentioned erythromycin micropill is carried out enteric coating: be about to above-mentioned erythromycin micropill and place BZJ-1000F II type coating pelletizing machine, starting coating pelletizing machine rotating speed is 50 rev/mins, restart the power gear pump of spray gun and spray gun, with the gear pump speed setting is 35 rev/mins, carry out the hydrojet coating: be about to the above-mentioned enteric coating liquid for preparing and evenly be sprayed on erythromycin micropill surface by spray gun, and in the enteric coating process, except the bottom of coating pelletizing machine has 1 air-blast device, also above the coating pelletizing machine, set up 2 air-blast devices, and when starting the coating pelletizing machine, open all air-blast devices, impel the enteric coated micropill energy in the coating process timely, be dried equably, improve the enteric coating work efficiency; After treating that coating solution has sprayed, close spray gun and gear pump, closing device takes out erythromycin enteric micropill, measures its content and release;
The enteric coating rate of body weight gain of d, gained erythromycin enteric micropill is 15% on (the plain ball when not carrying out coating relatively, as follows), incapsulate then product.
Embodiment 2:
Wherein the enteric coating liquid set of dispense ratio of enteric coated micropill sees Table 3.
In its preparation method: coating pelletizing machine rotating speed is 40 rev/mins in the c step; 30 rev/mins of spray gun power gear revolution speeds; set up 3 air-blast devices above the coating pelletizing machine, the enteric coating rate of body weight gain that detects the gained erythromycin enteric micropill in the d step is 12%.
All the other are with embodiment 1.
Embodiment 3:
Wherein the enteric coating liquid set of dispense ratio of enteric coated micropill sees Table 3:
In its preparation method: coating pelletizing machine rotating speed is 60 rev/mins in the c step; 40 rev/mins of spray gun power gear revolution speeds; set up 2 air-blast devices around the coating pelletizing machine, the enteric coating rate of body weight gain that detects the gained erythromycin enteric micropill in the d step is 18%.
All the other are with embodiment 1.
Embodiment 4:
Wherein the enteric coating liquid set of dispense ratio of enteric coated micropill sees Table 3.
In its preparation method: coating pelletizing machine rotating speed is 45 rev/mins in the c step; 30 rev/mins of spray gun power gear revolution speeds; set up 3 air-blast devices around the coating pelletizing machine, the enteric coating rate of body weight gain that detects the gained erythromycin enteric micropill in the d step is 16%.
All the other are with embodiment 1.
Embodiment 5:
Wherein the enteric coating liquid set of dispense ratio of enteric coated micropill sees Table 3.
In its preparation method: coating pelletizing machine rotating speed is 55 rev/mins in the c step; 40 rev/mins of spray gun power gear revolution speeds; set up 3 air-blast devices above the coating pelletizing machine, the enteric coating rate of body weight gain that detects the gained erythromycin enteric micropill in the d step is 13%.
All the other are with embodiment 1.
Table 3: the enteric coating liquid set of dispense ratio of enteric coated micropill among embodiment 2～embodiment 5
(by weight)
| Component | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 |
| Polyacrylic resin II | 1 | 1 | 1 | 1 |
| Diethyl phthalate | 0.08 | 0.085 | 0.09 | 0.1 |
| Soil temperature-80 | 0.09 | 0.1 | 0.11 | 0.12 |
| Oleum Ricini | 0.09 | 0.1 | 0.11 | 0.12 |
| Concentration is more than or equal to 95% ethanol | 12.5 | 13 | 13.5 | 14 |
| Enteric coating rate of body weight gain (%) | 12 | 18 | 16 | 13 |
Claims (6)
1, a kind of erythromycin enteric-coated capsule, it includes enteric coated micropill, the enteric coating liquid that it is characterized in that described enteric coated micropill is by polyacrylic resin II:1, diethyl phthalate: 0.07～0.1, soil temperature-80:0.08～0.12, Oleum Ricini: 0.08～0.12 and concentration more than or equal to 95% ethanol: 12～14 make; All by weight.
2, the preparation method of erythromycin enteric-coated capsule as claimed in claim 1 is characterized in that it may further comprise the steps:
A, by described enteric coating liquid set of dispense ratio, wherein polyacrylic resin II is dissolved in the ethanol of described proportioning, and then add remaining ingredient in the proportioning stir and dissolve after enteric coating liquid is standby;
B, will containing the erythromycin raw material for the treatment of effective dose and mixing acceptable accessories, to make the erythromycin micropill standby;
C, described erythromycin micropill is carried out enteric coating: be about to described erythromycin micropill and place the coating pelletizing machine; start the coating pelletizing machine; and the above-mentioned enteric coating liquid for preparing evenly be sprayed on erythromycin micropill surface by spray gun promptly get erythromycin enteric micropill, incapsulate product.
3, the preparation method of erythromycin enteric-coated capsule as claimed in claim 2, the erythromycin micropill particle diameter of wherein making in the b step is 0.6～0.8 millimeter; The coating rate of body weight gain of the enteric coated micropill that obtains in the c step is 12%～18%.
4, the preparation method of erythromycin enteric-coated capsule as claimed in claim 2, wherein the described coating pelletizing machine of c step is a BZJ-1000F II type coating pelletizing machine, its rotating speed is 40～60 rev/mins in the coating process.
5, the preparation method of erythromycin enteric-coated capsule as claimed in claim 2, wherein the described spray gun power of c step is gear pump, its rotating speed is 30～40 rev/mins in the coating process.
6, the preparation method of erythromycin enteric-coated capsule as claimed in claim 2 wherein in the described enteric coating process of c step, except the bottom of coating pelletizing machine has 1 air-blast device, also has additional air-blast device at other position of described coating pelletizing machine.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101919824A (en) * | 2010-06-21 | 2010-12-22 | 山东金洋药业有限公司 | High-release erythrocin enteric-coated tablet and preparation method thereof |
| CN102068412A (en) * | 2011-01-21 | 2011-05-25 | 黑龙江大学 | Enteric targeted tilmicosin particles and preparation method thereof |
| CN101502491B (en) * | 2009-03-09 | 2011-06-29 | 山东省医药工业研究所 | Dirithromycin enteric-coated formulation |
| CN102274191A (en) * | 2011-06-10 | 2011-12-14 | 浙江丽水众益药业有限公司 | Coating liquid composition of erythromycin enteric-coated pellet |
| CN102988302A (en) * | 2013-01-07 | 2013-03-27 | 深圳万和制药有限公司 | Erythromycin enteric capsule and preparation method thereof |
| CN103006574A (en) * | 2013-01-07 | 2013-04-03 | 深圳万和制药有限公司 | Stable erythromycin enteric-coated capsule and preparation method thereof |
| CN106924209A (en) * | 2017-05-07 | 2017-07-07 | 济南同路医药科技发展有限公司 | Erythromycin enteric-coated tabletses and preparation method thereof |
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2008
- 2008-03-13 CN CN200810069467A patent/CN100586427C/en active Active
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101502491B (en) * | 2009-03-09 | 2011-06-29 | 山东省医药工业研究所 | Dirithromycin enteric-coated formulation |
| CN101919824A (en) * | 2010-06-21 | 2010-12-22 | 山东金洋药业有限公司 | High-release erythrocin enteric-coated tablet and preparation method thereof |
| CN102068412A (en) * | 2011-01-21 | 2011-05-25 | 黑龙江大学 | Enteric targeted tilmicosin particles and preparation method thereof |
| CN102274191A (en) * | 2011-06-10 | 2011-12-14 | 浙江丽水众益药业有限公司 | Coating liquid composition of erythromycin enteric-coated pellet |
| CN102988302A (en) * | 2013-01-07 | 2013-03-27 | 深圳万和制药有限公司 | Erythromycin enteric capsule and preparation method thereof |
| CN103006574A (en) * | 2013-01-07 | 2013-04-03 | 深圳万和制药有限公司 | Stable erythromycin enteric-coated capsule and preparation method thereof |
| CN103006574B (en) * | 2013-01-07 | 2015-01-07 | 深圳万和制药有限公司 | Stable erythromycin enteric-coated capsule and preparation method thereof |
| CN102988302B (en) * | 2013-01-07 | 2015-04-29 | 深圳万和制药有限公司 | Erythromycin enteric capsule and preparation method thereof |
| CN106924209A (en) * | 2017-05-07 | 2017-07-07 | 济南同路医药科技发展有限公司 | Erythromycin enteric-coated tabletses and preparation method thereof |
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| CN100586427C (en) | 2010-02-03 |
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Assignee: SICHUAN TIANSHENG PHARMACEUTICAL CO., LTD. Assignor: Chongqing Tiansheng Pharmaceutical Co., Ltd. Contract record no.: 2011500000040 Denomination of invention: Erythromycin enteric-coated capsule and preparation thereof Granted publication date: 20100203 License type: Exclusive License Open date: 20080813 Record date: 20110622 |
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Owner name: TIANSHENG PHARMACEUTICAL GROUP CO., LTD. Free format text: FORMER NAME: CHONGQING TIANSHENG PHARMACEUTICAL CO., LTD. |
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Address after: Chaoyang Industrial Park, 408300 Chongqing County of Dianjiang city (Dianjiang Guixi) Patentee after: Tiansheng Pharmaceutical Group Co., Ltd. Address before: Chaoyang Industrial Park, 408300 Chongqing County of Dianjiang city (Dianjiang Guixi) Patentee before: Chongqing Tiansheng Pharmaceutical Co., Ltd. |