CN100381123C - Granules of clarityne and their production - Google Patents
Granules of clarityne and their production Download PDFInfo
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- CN100381123C CN100381123C CNB2005100376773A CN200510037677A CN100381123C CN 100381123 C CN100381123 C CN 100381123C CN B2005100376773 A CNB2005100376773 A CN B2005100376773A CN 200510037677 A CN200510037677 A CN 200510037677A CN 100381123 C CN100381123 C CN 100381123C
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- loratadine
- granule
- add
- citric acid
- food coloring
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Abstract
The present invention relates to a clarityne granule which is mainly prepared from clarityne and citric acid, wherein the mass compounding ratio of the clarityne to the citric acid is as follows: A gram of clarityne and (1-3)A gram of citric acid. The clarityne granule of the present invention can also contains the following ingredients: edible essence, a sweetening agent or/and edible pigment. The granule of the present invention contains the citric acid. Therefore, after the granule is dissolved in water, obtained solution is clear and transparent. The dependence of children medication is enhanced, and the biological availability of the clarityne can also be enhanced. The present invention has the key point that the citric acid is adopted, which leads the dissolved solution to be clear and transparent, and the clarityne which is taken can be thoroughly absorbed.
Description
One, technical field
The present invention relates to loratadine granule and preparation method thereof
Two, background technology:
Rapid-action during the loratadine clinical practice, effect is strong, belong to a new generation to the central nervous system do not have calm side reaction, have an optionally periphery H
1Receptor antagonist.The symptom and the sign of allergic rhinitis, chronic urticaria, itching skin disease and other anaphylaxis dermatosis can be effectively alleviated, flu or symptoms such as the sneeze, watery nasal discharge and the rhinocnesmus that cause of influenza, nasal obstruction can also be effectively alleviated.
Because the safety of loratadine is fine, be widely used at present.The dosage form of the loratadine on the market mostly is tablet and syrup greatly.The problem of taking of tablet and the sensory issues of syrup are that the loratadine clinical application is in the ubiquitous problem of child.
Three, summary of the invention
The present invention is not easy to the shortcoming accepted by the child at existing dosage form just, and a kind of loratadine granule that provides.
Technical scheme of the present invention is as follows:
A kind of loratadine granule, it mainly is made up of loratadine and citric acid, and their quality proportioning is: loratadine A gram, citric acid (1-3) A gram.
Above-mentioned loratadine granule can add edible essence (1-3) A gram in its component.
Above-mentioned loratadine granule can add sweeting agent (8-200) A gram in its component.Said sweeting agent can be sucrose, glucose, A Siba is sweet or stevioside.
Above-mentioned loratadine granule can add food coloring (0.3-0.6) A gram in its component.
Loratadine granule of the present invention can have wet granulation or two kinds of method for makings of dry granulation.
A kind of method for making of loratadine granule of the present invention, it is made up of the following step:
(1) former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves;
(2) get loratadine, citric acid, add or do not add sweeting agent, edible essence, mix, must mix powder;
(3) preparation of wet granular: after mixed powder adds binding agent, add 20% ethanol and mediate the system soft material, the wet grain of the 20 mesh sieve systems of crossing, said binding agent can be sodium carboxymethyl cellulose, polyvinylpyrrolidone (PVP) K30 polyvinylpyrrolidone (PVP) K90;
(4) drying:
The grain that will wet place 50 ℃-60 ℃ oven drying 3-4 hour, cross 18 mesh sieve granulate after, must do granule.
(5) with dried granule packaging, maybe will pack behind dried granule and the food coloring mixing, promptly get loratadine granule of the present invention.
A kind of method for making of loratadine granule of the present invention, it is made up of the following step:
(1) former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves;
(2) get loratadine, citric acid, add or do not add sweeting agent, edible essence, mix, must mix powder;
(3) the mixed powder of step 2 is added or not with the food coloring dry granulation, packing promptly gets loratadine granule of the present invention.
Granule of the present invention contains citric acid, thus after water-soluble, limpid transparent, not only make the compliance of children improve, can also improve the loratadine bioavailability.Key of the present invention is to have selected citric acid for use and make the solution clear of going out, and the absorption of taking loratadine is more complete.
Medicine of the present invention has following characteristics:
1, the present invention adopts granule, adds an amount of correctives and makes abnormal smells from the patient fragrance, and taste is fragrant and sweet, therefore is particularly suitable for children taking.
2, the present invention adds citric acid after the character of fully having studied loratadine.Be not only because after adding citric acid the solution clear that brews; The more important thing is that under acid condition, the dissolubility of loratadine is good.Owing to the relation of feed, the stomach pH value is higher after meal, and loratadine does not dissolve, and influences bioavailability, and environmental PH reduces in the stomach, and loratadine is easy to dissolving, improves bioavailability.
3, the present invention's half-life in vivo longer, only need take once every day, can have long-range curative effects, easy to use, the patient is easy to accept.
Four, the specific embodiment
The preparation (wet method) of embodiment 1. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get loratadine 5g, citric acid 5g,, cross 60 mesh sieves by equivalent incremental method mix homogeneously; After adding sodium carboxymethyl cellulose 15g, add 20% Diluted Alcohol solution again and make soft material in right amount, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃-60 ℃ dry 3-4 hour, cross 18 mesh sieve granulate, the aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (wet method) of embodiment 2. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get loratadine 5g, sucrose 1000g, citric acid 5g, strawberry essence 5g crosses 60 mesh sieves by equivalent incremental method mix homogeneously; After adding sodium carboxymethyl cellulose 15g, add 20% Diluted Alcohol solution again and make soft material in right amount, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃-60 ℃ dry 3-4 hour, cross 18 mesh sieve granulate, add food coloring 1.5g, the aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (dry method) of embodiment 3. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get loratadine 5g, glucose 1000g, citric acid 5g, strawberry essence 5g,, cross 60 mesh sieves by equivalent incremental method mix homogeneously; Cross 18 mesh sieve granulate, with food coloring 1.5g mixing.The aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (wet method) of embodiment 4. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get loratadine 5g, stevioside 40g, citric acid 5g, flavoring orange essence 5g,, cross 60 mesh sieves by equivalent incremental method mix homogeneously; Adding 20% Diluted Alcohol solution is an amount of after adding polyvinylpyrrolidone (PVP) K30 15g, system soft material, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃-60 ℃ dry 3-4 hour, cross 18 mesh sieve granulate, add food coloring 1.5g, the aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (dry method) of embodiment 5. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get loratadine 5g, stevioside 40g, citric acid 5g,, cross 60 mesh sieves by equivalent incremental method mix homogeneously; Cross 18 mesh sieve granulate, the aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (dry method) of embodiment 6. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get loratadine 5g, stevioside 40g, citric acid 5g, flavoring orange essence 5g,, cross 60 mesh sieves by equivalent incremental method mix homogeneously; Cross 18 mesh sieve granulate, with food coloring 1.5g mixing.The aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (wet method) of embodiment 7. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get the sweet 50g of loratadine 5g A Siba, citric acid 10g, strawberry essence 10g, cross 60 mesh sieves by equivalent incremental method mix homogeneously; After adding sodium carboxymethyl cellulose 20g, add 20% Diluted Alcohol solution and make soft material in right amount, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃-60 ℃ dry 3-4 hour, cross 18 mesh sieve granulate, add food coloring 2g, the aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (wet method) of embodiment 8. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get the sweet 50g of loratadine 5g, A Siba, citric acid 10g, strawberry essence 10g, cross 60 mesh sieves by equivalent incremental method mix homogeneously; After adding polyvinylpyrrolidone (PVP) K30 20g, add 20% Diluted Alcohol solution and make soft material in right amount, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃-60 ℃ dry 3-4 hour, cross 18 mesh sieve granulate, add food coloring 2g, the aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (dry method) of embodiment 9. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get the sweet 50g of loratadine 5g, A Siba, citric acid 10g, strawberry essence 10g,, cross 60 mesh sieves by equivalent incremental method mix homogeneously; Cross 18 mesh sieve granulate, with food coloring 2g mixing.The aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (wet method) of embodiment 10. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get loratadine 5g, stevioside 50g, citric acid 10g, flavoring orange essence 10g, cross 60 mesh sieves by equivalent incremental method mix homogeneously; After adding polyvinylpyrrolidone (PVP) K30 20g, add 20% Diluted Alcohol solution and make soft material in right amount, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃-60 ℃ dry 3-4 hour, cross 18 mesh sieve granulate, add food coloring 2g, the aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (wet method) of embodiment 11. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get loratadine 5g, stevioside 50g, citric acid 10g, flavoring orange essence 10g, cross 60 mesh sieves by equivalent incremental method mix homogeneously; After adding sodium carboxymethyl cellulose 20g, add 20% Diluted Alcohol solution and make soft material in right amount, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃-60 ℃ dry 3-4 hour, cross 18 mesh sieve granulate, add food coloring 2g, the aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (wet method) of embodiment 12. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get loratadine 5g, stevioside 50g, citric acid 10g, flavoring orange essence 10g,, cross 60 mesh sieves by equivalent incremental method mix homogeneously; After adding polyvinylpyrrolidone (PVP) K90 15g, add 20% Diluted Alcohol solution and make soft material in right amount, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃-60 ℃ dry 3-4 hour, cross 18 mesh sieve granulate, add food coloring 2g, the aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (wet method) of embodiment 13. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get the sweet 65g of loratadine 5g, A Siba, citric acid 15g, strawberry essence 15g,, cross 60 mesh sieves by equivalent incremental method mix homogeneously; After adding polyvinylpyrrolidone (PVP) K30 30g, add 20% Diluted Alcohol solution and make soft material in right amount, the wet grain of the 20 mesh sieve systems of crossing, 50 ℃-60 ℃ dry 3-4 hour, cross 18 mesh sieve granulate, add food coloring 3g, the aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
The preparation (dry method) of embodiment 14. loratadine granules
At first, former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, standby; Then, get loratadine 5g, stevioside 65g,, citric acid 15g, strawberry essence 15g, by equivalent incremental method mix homogeneously, cross 60 mesh sieves; Cross 18 mesh sieve granulate, with food coloring 3g mixing.The aluminum-plastic composite membrane packing, every bag 1g contains loratadine 5mg.
Claims (10)
1. loratadine granule, it is characterized in that: it mainly is made up of loratadine and citric acid, and their quality proportioning is: loratadine: citric acid=1: 1-3.
2. loratadine granule according to claim 1 is characterized in that: add edible essence in its component, the mass ratio of loratadine and edible essence is: loratadine: edible essence=1: 1-3.
3. loratadine granule according to claim 1 and 2 is characterized in that: add sweeting agent in its component, the mass ratio of loratadine and sweeting agent is: loratadine: sweeting agent=1: 8-200.
4. loratadine granule according to claim 3 is characterized in that: sweeting agent is sucrose, glucose, A Siba is sweet or stevioside.
5. loratadine granule according to claim 1 and 2 is characterized in that: add food coloring in its component, the mass ratio of loratadine and food coloring is: loratadine: food coloring=1: 0.3-0.6.
6. loratadine granule according to claim 3 is characterized in that: add food coloring in its component, the mass ratio of loratadine and food coloring is: loratadine: food coloring=1: 0.3-0.6.
7. method for preparing claim 1 or 2 described loratadine granules, it is made up of the following step:
(1) former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves;
(2) get loratadine, citric acid, add or do not add edible essence, mix, must mix powder;
(3) preparation of wet granular: after mixed powder adds binding agent, add 20% ethanol and mediate the system soft material, the wet grain of the 20 mesh sieve systems of crossing;
(4) drying:
The grain that will wet place 50 ℃-60 ℃ oven drying 3-4 hour, cross 18 mesh sieve granulate after, must do granule;
(5), maybe, promptly get the loratadine granule with packing behind dried granule and the food coloring mixing with dried granule packaging.
8. the method for making of loratadine granule according to claim 7 is characterized in that: in the step (2), also be added with sweeting agent.
9. method for preparing claim 1 or 2 described loratadine granules is characterized in that it is made up of the following step:
(1) former, adjuvant are all placed under 60 ℃ of conditions dry 4 hours, it is standby to cross 80 mesh sieves;
(2) get loratadine, citric acid, add or do not add edible essence, mix, must mix powder;
(3) the mixed powder of step 2 is added or not with the food coloring dry granulation, packing promptly gets the loratadine granule.
10. the method for making of loratadine granule according to claim 9 is characterized in that: in the step (2), also be added with sweeting agent.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100376773A CN100381123C (en) | 2005-01-12 | 2005-01-12 | Granules of clarityne and their production |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100376773A CN100381123C (en) | 2005-01-12 | 2005-01-12 | Granules of clarityne and their production |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1679567A CN1679567A (en) | 2005-10-12 |
| CN100381123C true CN100381123C (en) | 2008-04-16 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2005100376773A Expired - Fee Related CN100381123C (en) | 2005-01-12 | 2005-01-12 | Granules of clarityne and their production |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102038645B (en) * | 2009-10-12 | 2013-11-27 | 杭州赛利药物研究所有限公司 | Desloratadine grain and preparation method thereof |
| CN102525944A (en) * | 2012-01-11 | 2012-07-04 | 扬子江药业集团广州海瑞药业有限公司 | Desloratadine critrate disodium particles and preparation method for same |
| CN104224733B (en) * | 2014-09-30 | 2016-08-17 | 蔡伦 | A kind of loratadine granule and preparation method thereof |
| CN104997734A (en) * | 2015-06-25 | 2015-10-28 | 广州艾格生物科技有限公司 | Rupatadine fumarate granule and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1149071C (en) * | 1994-06-15 | 2004-05-12 | 杰哈德·盖尔盖伊 | Pharmaceutical preparation with a hydrophobic active substance and an effervescent system, and process for preparing said prparation |
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2005
- 2005-01-12 CN CNB2005100376773A patent/CN100381123C/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1149071C (en) * | 1994-06-15 | 2004-05-12 | 杰哈德·盖尔盖伊 | Pharmaceutical preparation with a hydrophobic active substance and an effervescent system, and process for preparing said prparation |
Non-Patent Citations (2)
| Title |
|---|
| 氯雷他定3种制剂生物等效性研究. 张全英，冒国光.中国新药与临床杂志，第23卷第9期. 2004 * |
| 药剂学. 毕殿洲，第297页，人民卫生出版社. 2001 * |
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| CN1679567A (en) | 2005-10-12 |
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