CN1857264A - Medicine composition with pioglitazone hydrochloride and glimepiride as active components and its preparing method and use - Google Patents
Medicine composition with pioglitazone hydrochloride and glimepiride as active components and its preparing method and use Download PDFInfo
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- CN1857264A CN1857264A CN 200610075609 CN200610075609A CN1857264A CN 1857264 A CN1857264 A CN 1857264A CN 200610075609 CN200610075609 CN 200610075609 CN 200610075609 A CN200610075609 A CN 200610075609A CN 1857264 A CN1857264 A CN 1857264A
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- glimepiride
- pioglitazone hydrochloride
- pharmaceutical composition
- active component
- tablet
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Abstract
The present invention relates to a kind of medicine composition with pioglitazone hydrochloride and glimepiride as active components and its preparation process and use. The medicine composition is used for treating type II diabetes. Pioglitazone hydrochloride and glimepiride as active components and certain amount of supplementary material are prepared into tablet, capsule, dispersant tablet, chewing tablet and other orally taken preparations.
Description
Technical field
The present invention relates to a kind of is Pharmaceutical composition of active component and preparation method thereof, purposes with pioglitazone hydrochloride and glimepiride, belongs to medical technical field.
Background technology
Diabetes (Diabetes mellitus) be since a kind of syndrome of the caused glucose of cellular metabolism effect defective, protein and the lipid metabolic disorder of insufficient insulin or insulin along with the fall ill prolongation of time of diabetes, the intravital metabolism disorder of body is controlled well as can not get, the chronic complicating diseases that can cause tissues such as eye, kidney, nerve, blood vessel and heart, organ, so that final take place blind, lower limb are gangrenous, uremia, apoplexy or myocardial infarction, even threat to life.Diabetes are a kind of commonly encountered diseases, and along with growth in the living standard, the sickness rate of diabetes increases year by year.The prevalence of developed country's diabetes is up to 5%-10%, and the prevalence of China has reached 3%.
Type 2 diabetes mellitus also is adult's morbidity type diabetes, how falls ill after 35-40 year, accounts for diabetics more than 90%.The ability that produces insulin in the type 2 diabetes mellitus ward mate body is not to completely lose, insulin even produce too much in the patient's body that has, but the action effect of insulin has a greatly reduced quality, so the intravital insulin of patient is a kind of relative shortage.
Pioglitazone hydrochloride is a kind of novel insulin sensitizer, and it does not stimulate insulin secretion, but by the intensifier target tissue to the sensitivity of insulin and onset, blood sugar reducing function is than strong ten times of troglitazones.The main peroxisome proliferation activated receptor-γ that activates in the fatty tissue.Can promote fatty tissue to express glucose transporter glut4, increase glucose uptake; Can also suppress the generation of tumor necrosis factor, reduce the release of free fatty, increase skeletal muscle and liver sensitivity, reduce glycogen output, increase the utilization of skeletal muscle, thereby increase the sensitivity of insulin, blood sugar lowering sugar to insulin.
Glimepiride is a second filial generation sulfonylurea oral hypoglycemic, and the dominant mechanism of its hypoglycemic activity is to stimulate the beta Cell of islet excreting insulin, and part improves the sensitivity of surrounding tissue to insulin.This product combine with Insulin receptor INSR and dissociative speed than glibenclamide for fast, lessly cause that heavier hypoglycemia can stimulate secretion of insulin in body by some oral drugs.But still have the part patient need as type 1 diabetes, carry out insulinize to the later stage.
This Pharmaceutical composition is to be the compound of active component with pioglitazone hydrochloride and glimepiride, it can be by increasing the secretion of insulin amount and improving the sensitivity of target tissue to insulin, have good synergistic, be used for the treatment of type 2 diabetes mellitus, have the exploitation meaning.
Summary of the invention
Having the purpose of this invention is to provide a kind of is Pharmaceutical composition of active component and uses thereof with pioglitazone hydrochloride and glimepiride.The present invention for a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, it is characterized in that it is the active component that pioglitazone hydrochloride and glimepiride form, the Pharmaceutical composition that forms with mixing acceptable accessories.
Above-mentioned a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, wherein the consumption of pioglitazone hydrochloride is 5mg-45mg for per unit dosage.Be preferably 10mg-30mg.
Above-mentioned a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, it is characterized in that the consumption of described glimepiride is 0.25mg-10mg for per unit dosage.Be preferably 0.5mg-5mg.。
Above-mentioned a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, it is characterized in that the weight ratio of described pioglitazone hydrochloride and glimepiride is 60: 1-7.5: 1.
Described a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, it is characterized in that the Pharmaceutical composition of described pioglitazone hydrochloride and glimepiride is an oral formulations.
Described a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, it is characterized in that described oral formulations can be made into tablet, capsule, dispersible tablet, chewable tablet, oral cavity disintegration tablet, buccal tablet, drop pill etc.
The specific embodiment
Come pioglitazone hydrochloride of the present invention and glimepiride preparation done further specifying by following example, but be not limited in following example.
Embodiment 1 pioglitazone hydrochloride and glimepiride tablet
Prescription:
Amounts of components
Pioglitazone hydrochloride 15g
Glimepiride 1g
Microcrystalline Cellulose 82g
CMS-Na 4g
Magnesium stearate 3g
90% ethanol is an amount of
Make 1000 altogether
Preparation method:
Pioglitazone hydrochloride, glimepiride, microcrystalline Cellulose are crossed 80 mesh sieves respectively, behind the mix homogeneously, add 90% ethanol and make soft material in right amount, 24 mesh sieves are granulated, drying, 20 mesh sieve granulate, add magnesium stearate, adopt suitable punch die compressed tablets behind the mix homogeneously, promptly.
Embodiment 2: pioglitazone hydrochloride and glimepiride capsule
Prescription:
Amounts of components
Pioglitazone hydrochloride 12g
Glimepiride 2g
Microcrystalline Cellulose 90g
80% alcoholic solution is an amount of
Magnesium stearate 3g
Preparation method:
Pioglitazone hydrochloride, glimepiride, microcrystalline Cellulose are crossed 80 mesh sieves respectively, behind the mix homogeneously, add 80% alcoholic solution and make soft material in right amount, 24 mesh sieves are granulated, drying, 24 mesh sieve granulate, the magnesium stearate that adds recipe quantity, in the suitable capsule shells of packing into behind the mix homogeneously promptly.
Embodiment 3: pioglitazone hydrochloride and glimepiride chewable tablet
Prescription:
Amounts of components
Pioglitazone hydrochloride 15g
Glimepiride 2g
Xylitol 105
Mannitol 250
Mentholum 8g
Orange flavor 6g
Aspartame 6g
The 2%PVP-k30 alcoholic solution is an amount of
Magnesium stearate 2g
Preparation method:
Pioglitazone hydrochloride, glimepiride, xylitol, mannitol, orange flavor, aspartame are crossed 80 mesh sieves respectively, behind the mix homogeneously, add the 2%PVP-k30 alcoholic solution and make soft material in right amount, 16 mesh sieves are granulated, drying, 12 mesh sieve granulate add Mentholum, magnesium stearate, tabletting behind the mix homogeneously, promptly.
Embodiment 4: pioglitazone hydrochloride and dispersive glimepiride tablet agent
Prescription
Amounts of components
Pioglitazone hydrochloride 15g
Glimepiride 1g
Microcrystalline Cellulose 154g
PPVP 12g
L-HPC 3g
Stevioside 4g
Orange flavor 10g
Micropowder silica gel 1g
75% alcoholic solution is an amount of
Preparation method:
Pioglitazone hydrochloride, glimepiride, microcrystalline Cellulose, about 1/3 amount PPVP and L-HPC are crossed 80 mesh sieves respectively, behind the mix homogeneously, add 75% alcoholic solution and make soft material in right amount, 16 mesh sieves are granulated, drying, 12 mesh sieve granulate, add surplus PPVP and L-HPC, stevioside, orange flavor, micropowder silica gel, behind the abundant mix homogeneously, tabletting, promptly.
Embodiment 5: pioglitazone hydrochloride and glimepiride oral cavity disintegration tablet
Prescription
Amounts of components
Pioglitazone hydrochloride 15g
Glimepiride 1g
Magnesiumaluminumsilicate 10g
L-HPC 16g
Mannitol 95g
Protein sugar 5.0g
Flavoring pineapple essence 5.0g
Magnesium stearate 3.0g
Preparation method:
Get above each supplementary material, all cross 120 mesh sieves, standby.Get glimepiride, progressively increase behind method and the Magnesiumaluminumsilicate mix homogeneously, add the mutual mix homogeneously of pioglitazone hydrochloride again according to equivalent, add L-HPC, mannitol, protein sugar, flavoring pineapple essence, magnesium stearate more successively, fully behind the mix homogeneously, adopt direct powder compression to carry out tabletting, promptly.
Embodiment 6: pioglitazone hydrochloride and glimepiride dripping pills agent
Prescription
Amounts of components
Pioglitazone hydrochloride 15g
Glimepiride 1g
PEG6000 30g
Ploxamer?188 14g
Make 1000 altogether
Preparation method:
Pioglitazone hydrochloride and glimepiride are crossed 80 mesh sieves, standby; In addition PEG6000, Ploxamer 188 are mixed post-heating and make fusion to about 60 ℃; Pioglitazone hydrochloride and glimepiride be heated in the fused solution stir, move in the dropping funnel, be incubated about 60 ℃, regulate the water dropper size, serves as the cooling phase with-25 ℃ dimethicones, the system of dripping, and ball is washed, selects in filtration, gets final product.
Claims (7)
- The present invention for a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, it is characterized in that it is the active component that pioglitazone hydrochloride and glimepiride form, the Pharmaceutical composition that forms with mixing acceptable accessories.
- 2. as claimed in claim 1 a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, it is characterized in that the consumption of described pioglitazone hydrochloride is 5mg-45mg for per unit dosage.Be preferably 10mg-30mg.
- 3. as claimed in claim 1 a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, it is characterized in that the consumption of described glimepiride is 0.25mg-10mg for per unit dosage.Be preferably 0.5mg-5mg.
- 4. as claimed in claim 1 a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, it is characterized in that the weight ratio of described pioglitazone hydrochloride and glimepiride is 60: 1-7.5: 1.
- 5. as claimed in claim 1 a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, it is characterized in that the Pharmaceutical composition of described pioglitazone hydrochloride and glimepiride is an oral formulations.
- 6. as claimed in claim 4 a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, it is characterized in that described oral formulations can be made into tablet, capsule, dispersible tablet, chewable tablet, oral cavity disintegration tablet, buccal tablet, drop pill etc.
- Claim 1-6 described a kind of be the Pharmaceutical composition of active component with pioglitazone hydrochloride and glimepiride, can be used for the treatment of diet control and the type 2 diabetes mellitus that still can not suitably control of motion.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN 200610075609 CN1857264A (en) | 2006-04-14 | 2006-04-14 | Medicine composition with pioglitazone hydrochloride and glimepiride as active components and its preparing method and use |
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CN 200610075609 CN1857264A (en) | 2006-04-14 | 2006-04-14 | Medicine composition with pioglitazone hydrochloride and glimepiride as active components and its preparing method and use |
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Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101804056A (en) * | 2010-04-16 | 2010-08-18 | 山东新华制药股份有限公司 | Compound tablet of pioglitazone hydrochloride, glimepiride and preparation method thereof |
CN102416004A (en) * | 2011-12-08 | 2012-04-18 | 扬子江药业集团广州海瑞药业有限公司 | Glimepiride tablets and preparation method thereof |
CN102512388A (en) * | 2011-12-26 | 2012-06-27 | 天津市嵩锐医药科技有限公司 | Glimepiride orally disintegrating medicine composition |
CN102641280A (en) * | 2012-04-23 | 2012-08-22 | 重庆康刻尔制药有限公司 | Pioglitazone hydrochloride and glimepiride combination medicine, tablet and application thereof |
CN101889633B (en) * | 2009-12-31 | 2012-11-07 | 华南农业大学 | Application of pioglitazone hydrochloride in live stock feed additive |
CN104173308A (en) * | 2014-08-30 | 2014-12-03 | 山东新时代药业有限公司 | Glimepiride dropping pill |
CN104288161A (en) * | 2014-09-19 | 2015-01-21 | 四川海思科制药有限公司 | Pharmaceutical composition containing pioglitazone and glimepiride |
CN104415042A (en) * | 2013-08-30 | 2015-03-18 | 天津药物研究院 | Co-amorphous system and preparation method thereof |
-
2006
- 2006-04-14 CN CN 200610075609 patent/CN1857264A/en active Pending
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101889633B (en) * | 2009-12-31 | 2012-11-07 | 华南农业大学 | Application of pioglitazone hydrochloride in live stock feed additive |
CN101804056A (en) * | 2010-04-16 | 2010-08-18 | 山东新华制药股份有限公司 | Compound tablet of pioglitazone hydrochloride, glimepiride and preparation method thereof |
CN102416004A (en) * | 2011-12-08 | 2012-04-18 | 扬子江药业集团广州海瑞药业有限公司 | Glimepiride tablets and preparation method thereof |
CN102512388A (en) * | 2011-12-26 | 2012-06-27 | 天津市嵩锐医药科技有限公司 | Glimepiride orally disintegrating medicine composition |
CN102641280A (en) * | 2012-04-23 | 2012-08-22 | 重庆康刻尔制药有限公司 | Pioglitazone hydrochloride and glimepiride combination medicine, tablet and application thereof |
CN104415042A (en) * | 2013-08-30 | 2015-03-18 | 天津药物研究院 | Co-amorphous system and preparation method thereof |
CN104173308A (en) * | 2014-08-30 | 2014-12-03 | 山东新时代药业有限公司 | Glimepiride dropping pill |
CN104173308B (en) * | 2014-08-30 | 2017-03-22 | 山东新时代药业有限公司 | Glimepiride dropping pill |
CN104288161A (en) * | 2014-09-19 | 2015-01-21 | 四川海思科制药有限公司 | Pharmaceutical composition containing pioglitazone and glimepiride |
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Open date: 20061108 |