CN1615862A - Miglitol oral disintegration tablet for treating diabetes II and its preparing method - Google Patents
Miglitol oral disintegration tablet for treating diabetes II and its preparing method Download PDFInfo
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- CN1615862A CN1615862A CNA200310108587XA CN200310108587A CN1615862A CN 1615862 A CN1615862 A CN 1615862A CN A200310108587X A CNA200310108587X A CN A200310108587XA CN 200310108587 A CN200310108587 A CN 200310108587A CN 1615862 A CN1615862 A CN 1615862A
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- miglitol
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- disintegration tablet
- oral cavity
- cavity disintegration
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Abstract
The orally disintegrated miglitol tablet for type-II diabetes consists of main medicine and supplementary material, the main medicine miglitol accounts for 5-50 % and is 10-200 mg in each tablet, and supplementary material consists of stuffing 5-30 wt%, disintegrating agent 5-45 wt%, disintegrating assistant 5-30 wt% and fine silica gel powder 0.1-3 wt% or consists of stuffing 5-30 wt%, disintegrating agent 5-45 wt%, disintegrating assistant 5-30 wt%, adhesive 5-15 wt% and lubricant 0.1-3 wt%. The disintegrated miglitol tablet is prepared with the material powder and through direct or wet tabletting. It is easy to take and can make full use of miglitol in treating diabetes effectively to lower the concentration of blood sugar after meal.
Description
[technical field]
The present invention relates to field of medicaments, specifically a kind of miglitol oral cavity disintegration tablet for the treatment of type ii diabetes and preparation method thereof.
[background technology]
Diabetes are diseases that modal a kind of endocrine metabolism imbalance causes.Diabetes are No. second diseases that are only second to cardiovascular disease, and the WHO survey result shows that there are several hundred million diabeticss in the whole world at present, wherein is the type ii diabetes patient more than 90%.Along with the raising of living standards of the people and the improvement of trophic structure, Chronic Non-Communicable Diseasess such as diabetes are being fashion trend.Zimmet and McCarty estimate, by 2010, the quantity of whole world diabetics will from 1994 111,000,000 rise to 239,000,000.The increase of diabetics quantity mainly concentrates in the Asia and Africa, estimate according to relevant research, to Asia in 2010 and African diabetes prevalence will improve 2-3 doubly than 1994.Annual newly-increased diabetics 1,200,000 people of China increase about 3000 people average every day.
The medicine of treatment diabetes mainly contains biguanides (as metformin), sulphanylureas (as gliclazide, glipizide, chlorpropamide etc.), alpha-glucosidase inhibitors (as acarbose, miglitol) and Thiazolidine diketone para-insulin sensitizer (as rosiglitazone, pioglitazone, troglitazone) etc.(Glyset Bay-m-1099) is a kind of novel antidiabetic drug of Bayer drugmaker research and development at the beginning of the eighties to miglitol for miglitol, Diastabol, chemistry is by name: [2R, 3R, 4R, 5S]-1-(2-ethoxy)-2-(methylol)-3,4,5-trihydroxy piperidines triol.Chemical structural formula is:
It is a kind of oral alpha-glucosidase inhibitor, is applicable to that (be non-insulin-depending type, NIDDM), its function mainly is to reduce patient's level of postprandial blood sugar to cooperation diet control treatment type ii diabetes, reduces the generation of diabetic complication.
The report of relevant miglitol medicine and research and development both at home and abroad all only relate to its common oral thin membrane coated tablet, take before the meal or follow first mouthful of meal to swallow or chew clothes for the patient.The general hardness of thin membrane coated tablet is bigger, often causes prolong disintegration, and the stripping of medicine, absorption and biological effect are also corresponding to slow down, and causes bioavailability to reduce; In addition, in oral process, thin membrane coated tablet is bigger to the danger of esophageall obstruetion and tissue injury, causes patient's compliance variation, and particularly for the old people, the patient of child and dysphagia makes troubles.
[summary of the invention]
The technical assignment of technical problem to be solved by this invention and proposition is the defective that overcomes above-mentioned prior art, and a kind of taking convenience, obvious results miglitol oral cavity disintegration tablet and preparation method thereof are provided.
Technical scheme of the present invention is such: a kind of miglitol oral cavity disintegration tablet for the treatment of type ii diabetes, it is characterized in that it forms (forming by weight percentage) by principal agent and adjuvant, wherein,
(1) principal agent: miglitol 5～50%, every contains 10～200mg;
(2) adjuvant: form by weight percentage,, adopt following two kinds of prescriptions according to different preparation methoies:
A, filler 5～30% help and collapse agent 5～30%, disintegrating agent 5～45% and micropowder silica gel 0.1～3%,
B, filler 5～30% help and collapse agent 5～30%, disintegrating agent 5～45%, binding agent 5～15% and lubricant 0.1～3%.
Can also add sweeting agent 0.05～10% among above-mentioned accessory formula a or the b or/and the agent 0.05～10% of tender flavor.
Miglitol oral cavity disintegration tablet of the present invention need not to chew, medicine is placed on the tongue, chance saliva was that rapid disintegrate becomes little material in 40 seconds, borrow swallowing act to go into the stomach onset, the competitive inhibition alpha-glucosidase reduces the degraded of saccharide at stomach, intestinal rapidly, delay the absorption of saccharide, thereby reduce the after-dinner blood sugar of diabetes patients peak concentration effectively, reach the purpose of blood sugar control, minimizing diabetic complication, the effect of more effective performance treatment diabetes.The patient that the miglitol oral cavity disintegration tablet also helps water intaking inconvenience under old man, dysphagia or the special environment takes, and has improved the compliance that the patient takes medicine greatly.
The miglitol oral cavity disintegration tablet of described treatment type ii diabetes, filler are mannitol, lactose, NaSO
4.10H
2A kind of or arbitrary combination among O, the Starch 1500.
The miglitol oral cavity disintegration tablet of described treatment diabetes helps that to collapse agent be microcrystalline Cellulose.
The miglitol oral cavity disintegration tablet of described treatment diabetes, disintegrating agent are a kind of or arbitrary combination in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, the processing agar.
The miglitol oral cavity disintegration tablet of described treatment diabetes, sweeting agent are a kind of or arbitrary combination in erythrol, Tablettose (TT), multitudinous sugar, protein sugar, maltose alcohol, saccharin sodium, the aspartame.
The miglitol oral cavity disintegration tablet of described treatment diabetes, the agent of tender flavor is a kind of or arbitrary combination of Mentholum, fruit essence, gelatin.
The miglitol oral cavity disintegration tablet of described treatment diabetes, binding agent are the hypromellose of 1～10%PVP slurry or 1～5%; Lubricant is magnesium stearate or Polyethylene Glycol.
A kind of method of preparation miglitol oral cavity disintegration tablet, with principal agent miglitol crushing screening, with direct compression behind the adjuvant mix homogeneously, temperature is 18～26 ℃ between tabletting, relative humidity control 45～65%, this is a direct compression of full-powder technology, at accessory formula a.
The another kind of method of preparation miglitol oral cavity disintegration tablet is with principal agent miglitol crushing screening, with filler, help and collapse agent adjuvant mix homogeneously, add binding agent then and make soft material, the granulation of sieving, oven dry, granulate, add other adjuvants such as disintegrating agent and lubricant afterwards, tabletting behind the abundant mixing, temperature is 18～26 ℃ between tabletting, relative humidity control 45～65%, this is a wet granulation technology, at accessory formula b.
The present invention fully takes into account the deficiency of existing miglitol drug administration mode, taking convenience, rapid competitive inhibition alpha-glucosidase, reduce the degraded of saccharide at stomach, intestinal, delay the absorption of saccharide, thereby reduce the after-dinner blood sugar of diabetes patients peak concentration effectively, reached the purpose of effective blood sugar control, minimizing diabetic complication, the effect of more effective performance miglitol treatment diabetes; The preparation method of miglitol oral cavity disintegration tablet is simple, need not special installation and technology.
[specific embodiment]
The invention will be further described below in conjunction with embodiment.
Embodiment 1
Prescription:
Miglitol 25g
Mannitol 25g
Microcrystalline Cellulose 80g
Low-substituted hydroxypropyl cellulose 20g
Cross-linking sodium carboxymethyl cellulose 25g
Micropowder silica gel 1.5g
Make 1000
Preparation process: accurately take by weighing the micropowder silica gel that adds behind miglitol in the prescription and the mannitol mixing in the prescription,, add direct powder compression behind the abundant mixing of other adjuvant again, promptly to increase the flowability of principal agent.
Embodiment 2
Prescription:
Miglitol 50g
Mannitol 25g
Microcrystalline Cellulose 80g
Low-substituted hydroxypropyl cellulose 20g
Cross-linking sodium carboxymethyl cellulose 20g
Mentholum 2g
Micropowder silica gel 2g
Make 1000
Preparation process: accurately take by weighing the micropowder silica gel that adds behind miglitol in the prescription and mannitol, the Mentholum mixing in the prescription,, add direct powder compression behind the abundant mixing of other adjuvant again, promptly to increase the flowability of principal agent.
Embodiment 3
Prescription:
Miglitol 25g
Mannitol 25g
Microcrystalline Cellulose 80g
Low-substituted hydroxypropyl cellulose 20g
Cross-linking sodium carboxymethyl cellulose 25g
1.5%PVP starches 8.5g
Magnesium stearate 2g
Make 1000
Preparation process: accurately take by weighing miglitol and mannitol mixing in the prescription, abundant mixing behind adding microcrystalline Cellulose and the low-substituted hydroxypropyl cellulose, add binding agent 1.5%PVP slurry and make soft material, cross 18 mesh sieves and make wet granular, drying is about one hour in about 60 ℃, take out cool slightly back and cross 16 mesh sieve granulate, add tabletting behind the abundant mixing of other adjuvant again, promptly.
Embodiment 4
Prescription:
Miglitol 50g
Mannitol 25g
Microcrystalline Cellulose 80g
Low-substituted hydroxypropyl cellulose 20g
Mentholum 2g
Cross-linking sodium carboxymethyl cellulose 25g
1.5%PVP starches 8.5g
Magnesium stearate 2g
Make 1000
Preparation process: accurately take by weighing miglitol in the prescription and mannitol, Mentholum mixing, abundant mixing behind microcrystalline Cellulose in the adding prescription and the low-substituted hydroxypropyl cellulose, add binding agent 1.5%PVP slurry and make suitable soft material, cross 18 mesh sieves and make wet granular, drying is about one hour in about 60 ℃, take out cool slightly back 16 mesh sieve granulate, add tabletting behind the abundant mixing of other adjuvant again, promptly.
Claims (10)
1, a kind of miglitol oral cavity disintegration tablet for the treatment of type ii diabetes is characterized in that it forms (forming by weight percentage) by principal agent and adjuvant, wherein,
(1) principal agent: miglitol 5～50%, every contains 10～200mg;
(2) adjuvant:, adopt following two kinds of prescriptions according to different preparation methoies:
A, filler 5～30% help and collapse agent 5～30%, disintegrating agent 5～45% and micropowder silica gel 0.1～3%,
B, filler 5～30% help and collapse agent 5～30%, disintegrating agent 5～45%, binding agent 5～15% and lubricant 0.1～3%.
2, the miglitol oral cavity disintegration tablet of treatment type ii diabetes according to claim 1 is characterized in that also comprising sweeting agent 0.05～10% among described adjuvant a or the b or/and the agent 0.05～10% of tender flavor.
3, the miglitol oral cavity disintegration tablet of treatment type ii diabetes according to claim 1 is characterized in that described filler is mannitol, lactose, NaSO
4.10H
2A kind of or arbitrary combination among O, the Starch 1500.
4, the miglitol oral cavity disintegration tablet of treatment type ii diabetes according to claim 1 is characterized in that describedly helping that to collapse agent be microcrystalline Cellulose.
5, the miglitol oral cavity disintegration tablet of treatment type ii diabetes according to claim 1 is characterized in that described disintegrating agent is a kind of or arbitrary combination in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, the processing agar.
6, the miglitol oral cavity disintegration tablet of treatment type ii diabetes according to claim 2 is characterized in that described sweeting agent is a kind of or arbitrary combination in erythrol, Tablettose (TT), multitudinous sugar, protein sugar, maltose alcohol, saccharin sodium, the aspartame.
7, the miglitol oral cavity disintegration tablet of treatment type ii diabetes according to claim 2 is characterized in that described tender flavor agent is a kind of or arbitrary combination of Mentholum, fruit essence, gelatin.
8, the miglitol oral cavity disintegration tablet of treatment type ii diabetes according to claim 1 is characterized in that described binding agent is the hypromellose of 1～10%PVP slurry or 1～5%; Lubricant is magnesium stearate or Polyethylene Glycol.
9, the method for preparing the miglitol oral cavity disintegration tablet is characterized in that principal agent miglitol crushing screening, and with direct powder compression behind the adjuvant mix homogeneously among the accessory formula a, temperature is 18～26 ℃ between tabletting, relative humidity control 45～65%.
10, the method for preparing the miglitol oral cavity disintegration tablet, it is characterized in that principal agent miglitol crushing screening, with filler among the accessory formula b, help and collapse agent adjuvant mix homogeneously, add binding agent then and make soft material, the granulation of sieving, oven dry, granulate adds other adjuvants such as disintegrating agent and lubricant afterwards, fully tabletting behind the mixing, temperature is 18～26 ℃ between tabletting, relative humidity control 45～65%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA200310108587XA CN1615862A (en) | 2003-11-10 | 2003-11-10 | Miglitol oral disintegration tablet for treating diabetes II and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA200310108587XA CN1615862A (en) | 2003-11-10 | 2003-11-10 | Miglitol oral disintegration tablet for treating diabetes II and its preparing method |
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| Publication Number | Publication Date |
|---|---|
| CN1615862A true CN1615862A (en) | 2005-05-18 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA200310108587XA Pending CN1615862A (en) | 2003-11-10 | 2003-11-10 | Miglitol oral disintegration tablet for treating diabetes II and its preparing method |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008012555A3 (en) * | 2006-07-27 | 2008-09-25 | Isis Innovation | Epitope reduction therapy |
| CN101289418B (en) * | 2007-04-19 | 2011-02-02 | 浙江医药股份有限公司新昌制药厂 | Miglitol crystal and method for preparing same |
| CN102210866A (en) * | 2011-06-03 | 2011-10-12 | 南开大学 | Oral preparation for slowing down absorption of alpha-glycosidase inhibitor and enhancing hypoglycemic drug effect |
| CN102600149A (en) * | 2012-02-02 | 2012-07-25 | 西藏易明西雅生物医药科技有限公司 | Pharmaceutical composition for treating diabetes |
| CN103070842A (en) * | 2013-01-31 | 2013-05-01 | 西安科技大学 | Preparation method of miglitol sustained release tablet |
| WO2015007676A1 (en) * | 2013-07-19 | 2015-01-22 | Bayer Pharma Aktiengesellschaft | Super quick disintegrating tablet formula for api miglitol |
| CN104644446A (en) * | 2013-11-25 | 2015-05-27 | 北京万生药业有限责任公司 | Preparing method of repaglinide medicinal preparation |
| CN105377303A (en) * | 2013-07-19 | 2016-03-02 | 株式会社三和化学研究所 | Orally disintegrating tablet |
| CN112220768A (en) * | 2020-10-15 | 2021-01-15 | 四川维奥制药有限公司 | Preparation method of miglitol tablets |
-
2003
- 2003-11-10 CN CNA200310108587XA patent/CN1615862A/en active Pending
Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008012555A3 (en) * | 2006-07-27 | 2008-09-25 | Isis Innovation | Epitope reduction therapy |
| CN101289418B (en) * | 2007-04-19 | 2011-02-02 | 浙江医药股份有限公司新昌制药厂 | Miglitol crystal and method for preparing same |
| CN102210866A (en) * | 2011-06-03 | 2011-10-12 | 南开大学 | Oral preparation for slowing down absorption of alpha-glycosidase inhibitor and enhancing hypoglycemic drug effect |
| CN102600149A (en) * | 2012-02-02 | 2012-07-25 | 西藏易明西雅生物医药科技有限公司 | Pharmaceutical composition for treating diabetes |
| CN103070842A (en) * | 2013-01-31 | 2013-05-01 | 西安科技大学 | Preparation method of miglitol sustained release tablet |
| CN103070842B (en) * | 2013-01-31 | 2014-07-02 | 西安科技大学 | Preparation method of miglitol sustained release tablet |
| WO2015007676A1 (en) * | 2013-07-19 | 2015-01-22 | Bayer Pharma Aktiengesellschaft | Super quick disintegrating tablet formula for api miglitol |
| CN105377303A (en) * | 2013-07-19 | 2016-03-02 | 株式会社三和化学研究所 | Orally disintegrating tablet |
| US20160136091A1 (en) * | 2013-07-19 | 2016-05-19 | Sanwa Kagaku Kenkyusho Co., Ltd. | Orally Disintegrating Tablet |
| JP2016533383A (en) * | 2013-07-19 | 2016-10-27 | バイエル ファーマ アクチエンゲゼルシャフト | Super fast disintegrating tablet formulation for API miglitol |
| CN104644446A (en) * | 2013-11-25 | 2015-05-27 | 北京万生药业有限责任公司 | Preparing method of repaglinide medicinal preparation |
| CN104644446B (en) * | 2013-11-25 | 2018-02-09 | 北京万生药业有限责任公司 | A kind of preparation method of Repaglinide pharmaceutical preparation |
| CN112220768A (en) * | 2020-10-15 | 2021-01-15 | 四川维奥制药有限公司 | Preparation method of miglitol tablets |
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