CN104188929A - Processing technology of ezetimibe tablet - Google Patents
Processing technology of ezetimibe tablet Download PDFInfo
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- CN104188929A CN104188929A CN201410481482.7A CN201410481482A CN104188929A CN 104188929 A CN104188929 A CN 104188929A CN 201410481482 A CN201410481482 A CN 201410481482A CN 104188929 A CN104188929 A CN 104188929A
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- processing technique
- ezetimibe
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Abstract
The invention discloses a processing technology of an ezetimibe tablet, which comprises the following steps: putting raw materials on a fluidized bed to granulate and obtaining a preparation with uniform particle size distribution, good dispersibility and stable tablet quality and without agglomeration phenomenon through controlling a certain wind speed and wind temperature as well as the speed and other parameters of a spray adhesive. The processing technology has the benefits that the spray nozzle clogging phenomenon is avoided during the preparation process, and the ezetimibe tablet is suitable for being industrially produced in large scale.
Description
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Technical field
The present invention relates to field of medicaments, particularly, relate to a kind of processing technique of Ezetimibe tablet.
Background technology
Ezetimibe is white crystalline powder, by Schering Plough and Merck & Co., Inc.'s R & D Cooperation for regulating the medicine of blood fat, be the cholesterol regulation inhibitor of first monocycle beta-lactam functional group of successfully synthesizing.Ezetimibe is very easily dissolved in ethanol, methanol and acetone, water insoluble, more stable under room temperature.
The model of action of Ezetimibe is unique, and its Main Function suppresses the absorption of cholesterol in small intestinal, and does not affect the absorption of other nutrient substance, and few to human body untoward reaction, and patient is better than other lipid lowerers to its toleration.
Ezetimibe can be alone clinically, also can combine utilization with Statins.Usually Ezetimibe being made to tablet at present takes.But tablet, in the process of taking, usually because rate of dissolution has limited the bioavailability of self, and then affects the treatment.
Suitable processing technique can access the preparation that tablet quality is good.Existing processing technique is more complicated in operation, the raising that is unfavorable for production efficiency, and the granule compressibility of producing is bad, and particle size distribution is inhomogeneous, is unfavorable for the carrying out of follow-up tablet forming technique.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of processing technique of Ezetimibe tablet, this process using is placed on raw material on fluid bed and granulates, by controlling the parameters such as speed of certain wind speed and air temperature and spray adhesive, can access particle size distribution evenly, favorable dispersibility, without agglomeration, the stable preparation of tablet quality, and preparation process spray nozzle clogging phenomenon can not occur, be applicable to large-scale industrial production.
The present invention addresses the above problem adopted technical scheme:
A processing technique for Ezetimibe tablet, comprises the following steps:
After Ezetimibe, sodium lauryl sulphate, cross-linking sodium carboxymethyl cellulose, lactose being stirred in High Speed Stirring Machine by recipe quantity, be placed on fluid bed, apply the air intake of suitable speed; and control inlet temperature; after pressurized jet binder solution, granulate again, tabletting.
Further, described binding agent is: PVP K30 and 30% ethanol.
Further, the mixing speed of described High Speed Stirring Machine is 600-700rpm.
Further, described intake velocity is 20-35Hz, and inlet temperature is 70-85 ℃.
Further, described moulding pressure is 2-3Mpa.
Further, the jet velocity of spray adhesive solution is 5-10ml/min.
To sum up, the invention has the beneficial effects as follows:
The present invention adopts raw material is placed on fluid bed and is granulated, by controlling the parameters such as speed of certain wind speed and air temperature and spray adhesive, can access particle size distribution evenly, favorable dispersibility, without agglomeration, the stable preparation of tablet quality, and preparation process spray nozzle clogging phenomenon can not occur, be applicable to large-scale industrial production.
The specific embodiment
Below in conjunction with embodiment, the present invention is done to detailed description further, but embodiments of the present invention are not limited to this.
During enforcement, select being combined as of Ezetimibe sheet:
Ezetimibe 280-320
Lactose 2100-2400
Cross-linking sodium carboxymethyl cellulose 270-300
Sodium lauryl sulphate 50-80
PVP K30 80
Magnesium stearate 28-30
30% ethanol 720.
embodiment 1:
A processing technique for Ezetimibe tablet, comprises the following steps:
After Ezetimibe, sodium lauryl sulphate, cross-linking sodium carboxymethyl cellulose, lactose being stirred in High Speed Stirring Machine by recipe quantity; be placed on fluid bed; apply the air intake of suitable speed; and control inlet temperature; again after pressurized jet PVP K30 and 30% alcoholic solution; granulate, tabletting.
The mixing speed of described High Speed Stirring Machine is 600rpm.
Described intake velocity is 20Hz, and inlet temperature is 70 ℃.
Described moulding pressure is 2-3Mpa.
The jet velocity of spray adhesive solution is 5ml/min.
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embodiment 2:
a processing technique for Ezetimibe tablet, comprises the following steps:
After Ezetimibe, sodium lauryl sulphate, cross-linking sodium carboxymethyl cellulose, lactose being stirred in High Speed Stirring Machine by recipe quantity; be placed on fluid bed; apply the air intake of suitable speed; and control inlet temperature; again after pressurized jet PVP K30 and 30% alcoholic solution; granulate, tabletting.
The mixing speed of described High Speed Stirring Machine is 700rpm.
Described intake velocity is 35Hz, and inlet temperature is 85 ℃.
Described moulding pressure is 2-3Mpa.
The jet velocity of spray adhesive solution is 8ml/min.
embodiment 3
a processing technique for Ezetimibe tablet, comprises the following steps:
After Ezetimibe, sodium lauryl sulphate, cross-linking sodium carboxymethyl cellulose, lactose being stirred in High Speed Stirring Machine by recipe quantity; be placed on fluid bed; apply the air intake of suitable speed; and control inlet temperature; again after pressurized jet PVP K30 and 30% alcoholic solution; granulate, tabletting.
The mixing speed of described High Speed Stirring Machine is 650rpm.
Described intake velocity is 25Hz, and inlet temperature is 75 ℃.
Described moulding pressure is 2-3Mpa.
The jet velocity of spray adhesive solution is 10ml/min.
embodiment 4
A processing technique for Ezetimibe tablet, comprises the following steps:
After Ezetimibe, sodium lauryl sulphate, cross-linking sodium carboxymethyl cellulose, lactose being stirred in High Speed Stirring Machine by recipe quantity; be placed on fluid bed; apply the air intake of suitable speed; and control inlet temperature; again after pressurized jet PVP K30 and 30% alcoholic solution; granulate, tabletting.
The mixing speed of described High Speed Stirring Machine is 680rpm.
Described intake velocity is 30Hz, and inlet temperature is 80 ℃.
Described moulding pressure is 2-3Mpa.
The jet velocity of spray adhesive solution is 9ml/min.
As mentioned above, can realize preferably the present invention.
Claims (6)
1. a processing technique for Ezetimibe tablet, is characterized in that, comprises the following steps:
After Ezetimibe, sodium lauryl sulphate, cross-linking sodium carboxymethyl cellulose, lactose being stirred in High Speed Stirring Machine by recipe quantity, be placed on fluid bed, apply the air intake of suitable speed; and control inlet temperature; after pressurized jet binder solution, granulate again, tabletting.
2. processing technique according to claim 1, is characterized in that, described binding agent is: PVP K30 and 30% ethanol.
3. processing technique according to claim 2, is characterized in that, the mixing speed of described High Speed Stirring Machine is 600-700rpm.
4. processing technique according to claim 1, is characterized in that, described intake velocity is 20-35Hz, and inlet temperature is 70-85 ℃.
5. processing technique according to claim 1, is characterized in that, described moulding pressure is 2-3Mpa.
6. processing technique according to claim 1, is characterized in that, the jet velocity of spray adhesive solution is 5-10ml/min.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410481482.7A CN104188929A (en) | 2014-09-21 | 2014-09-21 | Processing technology of ezetimibe tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410481482.7A CN104188929A (en) | 2014-09-21 | 2014-09-21 | Processing technology of ezetimibe tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN104188929A true CN104188929A (en) | 2014-12-10 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410481482.7A Pending CN104188929A (en) | 2014-09-21 | 2014-09-21 | Processing technology of ezetimibe tablet |
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| CN (1) | CN104188929A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104825407A (en) * | 2015-04-20 | 2015-08-12 | 山东新时代药业有限公司 | Ezetimibe tablet |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2368543A1 (en) * | 2010-03-25 | 2011-09-28 | KRKA, tovarna zdravil, d.d., Novo mesto | Method of preparing a granulated pharmaceutical composition comprising simvastatin and/or ezetimibe |
| CN103655481A (en) * | 2012-09-18 | 2014-03-26 | 江苏柯菲平医药有限公司 | Preparation method of ezetimibe orally-taken preparation |
| CN103655453A (en) * | 2013-12-27 | 2014-03-26 | 华润赛科药业有限责任公司 | Preparation method of ezetimibe medicine composition |
-
2014
- 2014-09-21 CN CN201410481482.7A patent/CN104188929A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2368543A1 (en) * | 2010-03-25 | 2011-09-28 | KRKA, tovarna zdravil, d.d., Novo mesto | Method of preparing a granulated pharmaceutical composition comprising simvastatin and/or ezetimibe |
| CN103655481A (en) * | 2012-09-18 | 2014-03-26 | 江苏柯菲平医药有限公司 | Preparation method of ezetimibe orally-taken preparation |
| CN103655453A (en) * | 2013-12-27 | 2014-03-26 | 华润赛科药业有限责任公司 | Preparation method of ezetimibe medicine composition |
Non-Patent Citations (1)
| Title |
|---|
| 何培源,等: "依折麦布临床研究最新进展", 《心血管病学进展》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104825407A (en) * | 2015-04-20 | 2015-08-12 | 山东新时代药业有限公司 | Ezetimibe tablet |
| CN104825407B (en) * | 2015-04-20 | 2018-05-18 | 山东新时代药业有限公司 | A kind of Ezetimibe tablet |
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| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20141210 |
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| RJ01 | Rejection of invention patent application after publication |