CN101695481A - Mitiglinide calcium dispersible tablet and preparation method thereof - Google Patents
Mitiglinide calcium dispersible tablet and preparation method thereof Download PDFInfo
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- CN101695481A CN101695481A CN200910186302A CN200910186302A CN101695481A CN 101695481 A CN101695481 A CN 101695481A CN 200910186302 A CN200910186302 A CN 200910186302A CN 200910186302 A CN200910186302 A CN 200910186302A CN 101695481 A CN101695481 A CN 101695481A
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Abstract
The invention relates to a mitiglinide calcium dispersible tablet which is characterized by comprising the following materials parting parts by weight: 4-6 parts of mitiglinide calcium, 60-90 parts of starch, 12-18 parts of microcrystalline cellulose, 12.8-19.2 parts of dextrin, 0.8-1.2 parts of magnesium stearate and the balance of pure water. The invention has the advantages of rapid effect of blood sugar, short duration, capability of tabletting, good hardness and better disintegration.
Description
Technical field
The present invention relates to a kind of dispersible tablet, relate in particular to a kind of Mitiglinide calcium dispersible tablet and preparation method thereof.
Background technology
At present, treatment Rezulin medicine preferably is a Mitiglinide Calcium, Mitiglinide Calcium mechanism of action novelty, rapid-action, and traditional oral Rezulin continues to stimulate insulin secretion, and uses this medicine that the patient is felt hungry, and makes weight increase thereby cause the patient to continue feed.
Summary of the invention
The object of the present invention is to provide a kind of Mitiglinide calcium dispersible tablet and preparation method thereof, Mitiglinide calcium dispersible tablet is blood sugar lowering class medicine after the meal, and is rapid-action, safe.
The present invention is achieved like this, and it is characterized in that being made up of following raw materials in part by weight:
Mitiglinide Calcium 4-6 part, starch 60-90 part, microcrystalline Cellulose 12-18 part, dextrin 12.8-19.2, magnesium stearate (outward) 0.8-1.2 part, pure water surplus;
Optimum weight raw material is: 5 parts of Mitiglinide Calciums, 75 parts of starch, 15 parts of microcrystalline Cellulose, dextrin 16,1.0 parts of magnesium stearate (outward), pure water surplus;
Its preparation method is:
(1) respectively each supplementary material was pulverized 100 mesh sieves, standby;
(2) with the Mitiglinide Calcium of recipe quantity with the equivalent abundant mixing of method and microcrystalline Cellulose and starch that progressively increases;
(3) again dextrin, the magnesium stearate that adds in the recipe quantity together added in the blender, do and mixed 20-40 minute;
(4) with adding pure water in the supplementary material that mixes, be mixed and made into soft material, granulate with 30 eye mesh screens;
(5) with granule in 45 ± 5 ℃ of electrically heated drying cabinets dry 4-5 hour;
(6) adjuvant that recipe quantity is added adds in the dried granule, with 30 mesh sieve granulate, mix homogeneously;
(7) the tabletting packing gets final product.
Advantage of the present invention is: blood glucose is rapid-action, and acting duration is short, but tabletting, hardness is good, and disintegration is better.
The specific embodiment
Embodiment 1
(1) respectively 5 parts of Mitiglinide Calciums, 75 parts of starch, 15 parts of microcrystalline Cellulose, dextrin 16, magnesium stearate (outward) were pulverized 100 mesh sieves for 1.0 parts, standby;
(2) with the Mitiglinide Calcium of recipe quantity with the equivalent abundant mixing of method and microcrystalline Cellulose and starch that progressively increases;
(3) again dextrin, the magnesium stearate that adds in the recipe quantity together added in the blender, do and mixed 30 minutes;
(4) with adding pure water in the supplementary material that mixes, be mixed and made into soft material, granulate with 30 eye mesh screens;
(5) with granule in 45 ℃ of electrically heated drying cabinets dry 4.5 hours;
(6) adjuvant that recipe quantity is added adds in the dried granule, with 30 mesh sieve granulate, mix homogeneously;
(7) the tabletting packing gets final product.
Embodiment 2
(1) respectively 4 parts of Mitiglinide Calciums, 60 parts of starch, 12 parts of microcrystalline Cellulose, dextrin 12.8, magnesium stearate (outward) were pulverized 100 mesh sieves for 0.8 part, standby;
(2) with the Mitiglinide Calcium of recipe quantity with the equivalent abundant mixing of method and microcrystalline Cellulose and starch that progressively increases;
(3) again dextrin, the magnesium stearate that adds in the recipe quantity together added in the blender, do and mixed 20 minutes;
(4) with adding pure water in the supplementary material that mixes, be mixed and made into soft material, granulate with 30 eye mesh screens;
(5) with granule in 40 ℃ of electrically heated drying cabinets dry 4 hours;
(6) adjuvant that recipe quantity is added adds in the dried granule, with 30 mesh sieve granulate, mix homogeneously;
(7) the tabletting packing gets final product.
Embodiment 3
(1) respectively 6 parts of Mitiglinide Calciums, 90 parts of starch, 18 parts of microcrystalline Cellulose, dextrin 19.2, magnesium stearate (outward) were pulverized 100 mesh sieves for 1.2 parts, standby;
(2) with the Mitiglinide Calcium of recipe quantity with the equivalent abundant mixing of method and microcrystalline Cellulose and starch that progressively increases;
(3) again dextrin, the magnesium stearate that adds in the recipe quantity together added in the blender, do and mixed 40 minutes;
(4) with adding pure water in the supplementary material that mixes, be mixed and made into soft material, granulate with 30 eye mesh screens;
(5) with granule in 50 ℃ of electrically heated drying cabinets dry 5 hours;
(6) adjuvant that recipe quantity is added adds in the dried granule, with 30 mesh sieve granulate, mix homogeneously;
(7) the tabletting packing gets final product.
The prescription foundation
This prescription according to the physicochemical properties such as dissolubility of its crude drug in different solvents, carries out the prescription screening design based on Mitiglinide Calcium character.Its dissolubility in several primary solvents sees Table 1.
The solubility table of table 1 Mitiglinide Calcium in several primary solvents
Prescription screening
Design following prescription according to its physicochemical property, by investigating mobility of particle, unilateral apparent situation, hardness, disintegration, projects such as dispersing uniformity are screened the Mitiglinide calcium dispersible tablet prescription, see Table 2.
Table 2 specification 5mg Mitiglinide calcium dispersible tablet prescription screening table
Make 1000
Investigate by requirement under 2000 editions tablet items of Chinese Pharmacopoeia, the results are shown in Table 3.
Table 3 specification 5mg prescription screening result
Prescription | ??1 | ??2 | ??3 | ??4 |
Mobility of particle | Better | Better | Better | Good |
Unilateral | Better | Better | Better | Good |
Hardness | Better | Better | Good | Good |
Dispersing uniformity | Better | Better | Better | Good |
Disintegrate | 5 minutes | 4 minutes | 2.5 minute | 2 minutes |
1, the prescription 1, the prescription 2 mobility of particles better, but tabletting, hardness is good, disintegrate is better.
2, prescription 3 mobility of particles are better, but tabletting, it is unilateral that better hardness reaches requirement, and disintegrate is comparatively desirable.
3, prescription 4 is changed on prescription 3 bases, and mobility of particle is good, but tabletting is unilateral good,
Hardness, disintegration are all comparatively desirable, and granule more carefully can be by No. 2 sieves after the disintegrate.
Go up according to this screening experiment, selecting prescription 4 is best prescription.
Various supplementary material effects
Claims (3)
1. Mitiglinide calcium dispersible tablet is characterized in that being made up of following raw materials in part by weight:
Mitiglinide Calcium 4-6 part, starch 60-90 part, microcrystalline Cellulose 12-18 part, dextrin 12.8-19.2, magnesium stearate 0.8-1.2 part, pure water surplus.
2. Mitiglinide calcium dispersible tablet according to claim 1 is characterized in that optimum weight raw material is: 5 parts of Mitiglinide Calciums, 75 parts of starch, 15 parts of microcrystalline Cellulose, dextrin 16,1.0 parts of magnesium stearate, pure water surplus.
3. the preparation method of the described Mitiglinide calcium dispersible tablet of claim 1 is characterized in that being:
(1) respectively each supplementary material was pulverized 100 mesh sieves, standby;
(2) with the Mitiglinide Calcium of recipe quantity with the equivalent abundant mixing of method and microcrystalline Cellulose and starch that progressively increases;
(3) again dextrin, the magnesium stearate that adds in the recipe quantity together added in the blender, do and mixed 20-40 minute;
(4) with adding pure water in the supplementary material that mixes, be mixed and made into soft material, granulate with 30 eye mesh screens;
(5) with granule in 45 ± 5 ℃ of electrically heated drying cabinets dry 4-5 hour;
(6) adjuvant that recipe quantity is added adds in the dried granule, with 30 mesh sieve granulate, mix homogeneously;
(7) the tabletting packing gets final product.
Priority Applications (1)
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CN200910186302A CN101695481A (en) | 2009-10-23 | 2009-10-23 | Mitiglinide calcium dispersible tablet and preparation method thereof |
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CN200910186302A CN101695481A (en) | 2009-10-23 | 2009-10-23 | Mitiglinide calcium dispersible tablet and preparation method thereof |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101905027A (en) * | 2010-07-27 | 2010-12-08 | 北京华禧联合科技发展有限公司 | Oral pharmaceutical composition containing mitiglinide calcium and cyclodextrin |
CN103565764A (en) * | 2013-11-26 | 2014-02-12 | 重庆科瑞南海制药有限责任公司 | Mitiglinide calcium composition tablets and preparation method thereof |
CN106880608A (en) * | 2015-12-15 | 2017-06-23 | 北大方正集团有限公司 | A kind of teriflunomide dispersible tablet and preparation method thereof |
-
2009
- 2009-10-23 CN CN200910186302A patent/CN101695481A/en active Pending
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101905027A (en) * | 2010-07-27 | 2010-12-08 | 北京华禧联合科技发展有限公司 | Oral pharmaceutical composition containing mitiglinide calcium and cyclodextrin |
CN103565764A (en) * | 2013-11-26 | 2014-02-12 | 重庆科瑞南海制药有限责任公司 | Mitiglinide calcium composition tablets and preparation method thereof |
CN103565764B (en) * | 2013-11-26 | 2016-08-31 | 重庆科瑞南海制药有限责任公司 | mitiglinide calcium composition tablet and preparation method thereof |
CN106880608A (en) * | 2015-12-15 | 2017-06-23 | 北大方正集团有限公司 | A kind of teriflunomide dispersible tablet and preparation method thereof |
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Open date: 20100421 |