CN1726912A - Slow release capsule of compound metformin pyrrolidone and preparation method - Google Patents
Slow release capsule of compound metformin pyrrolidone and preparation method Download PDFInfo
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- CN1726912A CN1726912A CN 200510014596 CN200510014596A CN1726912A CN 1726912 A CN1726912 A CN 1726912A CN 200510014596 CN200510014596 CN 200510014596 CN 200510014596 A CN200510014596 A CN 200510014596A CN 1726912 A CN1726912 A CN 1726912A
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Abstract
A slow-releasing capsule of compound fluamine pyrrolinone for treating diabetes is composed of the central slow-releasing fluamine microball or small tablet and the coated fast-releasing pyrrolinone layer. Its advantages are high curative effect and no toxic by-effect.
Description
Technical field
The invention belongs to the pharmaceutical preparations technology field, relate to a kind of slow release capsule of compound metformin pyrrolidone and preparation method thereof.
Background technology
Metformin is the biguanides antihyperglycemic.It produces glucose and increases the periphery ingestion of glucose by suppressing liver, reduces insulin resistance and blood sugar lowering.Pioglitazone is the thiazolidinediones euglycemic agent, and it is relevant that its mechanism of action and insulin exist, and can reduce the insulin resistance of peripheral tissues and liver, and the glucose that increases insulin is handled, and reduces glycogen output.
When using metformin treatment hyperglycemia disease separately, in order to keep effective treatment blood drug level, reduction side effect, increase patient's compliance, metformin hydrochloride is made into to take in 1st one time slow releasing preparation, as the Glucophagrtm XR of the U.S. hundred Shi Mei companies (Bristol-Myers Squibb Co.), its slow release method is open at world patent wo9608243.
Because diabetes are chronic metabolic diseases, still can not effect a radical cure at present, need be according to the comprehensively comprehensive long-term treatment of individual patient situation, by strict blood sugar control, to prevent and to delay the generation and the development of chronic complicating diseases of diabetes.Therefore, when the treatment diabetes, medication combined application is an effective means.
Metformin is particularly obese patient's a choice drug of light, moderate II type diabetes patient, when using the metformin poor blood glucose control separately, with the pioglitazone use in conjunction, effect concentrates on metabolic deficiency, more effective blood sugar control, and reduce hypoglycemic incidence rate.Owing to obviously reduce when the consumption of metformin and pioglitazone uses more separately during use in conjunction, therefore,, also reduced toxic and side effects in the synergistic while of performance two medicines.
In order to bring into play the characteristics of two medicine Synergistic treatments, delay metformin by preparation technique and discharge in vivo, the compound metformin pyrrolidone slow releasing preparation of making is taken medicine metformin pyrrolidone synchronously, makes things convenient for the patient to take.
The technology of by literature search metformin hydrochloride and pioglitazone use in conjunction being made slow-release micro-pill or making small of slow release is not seen any bibliographical information as yet.
Summary of the invention
The object of the present invention is to provide the safer effective slow release capsule of compound metformin pyrrolidone of a kind of treatment diabetes.Said preparation has high bioavailability, and continues absorbent properties with gastrointestinal and combine, thus reach take every day once after, in human body, reach continuous release, the effect that blood sugar level is steadily controlled.
Another object of the present invention is to provide a kind of preparation method of slow release capsule of compound metformin pyrrolidone.
The present invention is achieved by following technical solution:
Metformin of the present invention is metformin hydrochloride or its pharmaceutically acceptable salt example hydrochloric acid salt, acetate, benzoate, mesylate, maleate etc., yet, preferably use metformin itself or its hydrochlorate.
Pioglitazone of the present invention is that pioglitazone hydrochloride or its pharmaceutically acceptable salt are as comprising hydrochlorate, formates, fumarate, acetate, benzoate, mesylate, sulfate, maleate etc., yet, preferably use pioglitazone itself or its hydrochlorate.
Slow release capsule of compound metformin pyrrolidone, containing the slow-release micro-pill of metformin or slow release small pieces and skin by internal layer contains rapid release pioglitazone film-coat layer and forms, or metformin slow-release micro-pill and pioglitazone fast release micropill composition, wherein contain 5～60mg pioglitazone and the metformin that is no more than 3000mg.
The rapid release pioglitazone film-coat that contains of the present invention consists of: 1. 2. 3. 0～40% binding agent of 0～40% Opadry of 50～99% pioglitazones.
Wherein, describedly contain consisting of of metformin slow-release micro-pill or small pieces:
1. contain pill core or label: 50～98% metformin, 0～50% high molecular polymer, 0～50% organic acid or alcohol, 0.1～40% binding agent, 0～5% lubricant;
2. contain pill core or label outsourcing slow release film-coat layer: 50～99% high molecular polymers, 0～25% plasticizer, 0～25% porogen, 0～10% antiplastering aid.
Wherein, the high molecular polymer that contains in pill core or the label is water soluble polymer (as sodium alginate, xanthan gum, hydroxyethyl-cellulose, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, chitin, polyvinyl alcohol) or water-insoluble macromolecular polymer (as ethyl cellulose, acrylic resin) or organic alcohol, fatty acid and ester thereof (as stearic acid, Brazil wax, glyceryl monostearate, octadecanol); The high polymer that contains in the outer slow release film-coat of pill core or the label layer is polyacrylic resin, cellulose acetate, ethyl cellulose.
The metformin slow-release micro-pill is by containing pill core and coatings is formed.Contain pill core and can load medicine by celphere and make, or metformin and high polymer be mixed and made into carry a pill core, the latter has better slow release effect.Coatings is made up of slow release filmogen, porogen, plasticizer.Celphere can be selected microcrystalline Cellulose ball core, sucrose ball core or their mixture for use.High polymer can be water soluble polymer or water-insoluble high polymer or fatty acid and ester thereof in the pill core by carrying of being mixed and made into of principal agent and high polymer.Preferred fatty acid and the ester thereof of using.Slow-release material in the coatings can be ethyl cellulose, cellulose acetate, acrylic resin.Plasticizer can be propylene glycol, Polyethylene Glycol, triethyl citrate, tributyl citrate, acetyl group triethyl citrate, acetyl group tributyl citrate, dimethyl phthalate, diethyl phthalate, phthalic acid dibutyl ester, certain herbaceous plants with big flowers two dibutyl phthalates.Porogen can be Polyethylene Glycol, polyvidone, sucrose, salt, hydroxyethyl-cellulose, hydroxypropyl methylcellulose.
Rapid release pioglitazone coatings can be dispersed in pioglitazone in the solution that contains binding agent, gets final product in the outer coating medicine-feeding of metformin slow-release micro-pill.
The pioglitazone fast release micropill can load that medicine is made or principal agent and mixing diluents are made the medicine carrying micropill by celphere.
Metformin slow release small pieces are made by pastille label and coatings, and metformin pastille label can add the small pieces that medicinal adjuvant is granulated, is pressed into 2mm ~ 5mm by principal agent; Coatings is made up of slow release filmogen, porogen, plasticizer.Pharmaceutic adjuvant in the small pieces by diluent (as microcrystalline Cellulose, starch, sucrose etc.), blocker is (as the water soluble polymer sodium alginate, xanthan gum, hydroxyethyl-cellulose, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, chitin, polyvinyl alcohol, or water-insoluble high polymer such as ethyl cellulose, acrylic resin, or fatty acid and ester such as stearic acid, Brazil wax, glyceryl monostearate, octadecanol), binding agent is (as polyvidone, hydroxypropyl emthylcellulose, starch, sucrose), lubricant is (as magnesium stearate, silicon dioxide, Pulvis Talci) forms.The coatings prescription is formed can be with reference to the metformin slow-release micro-pill.
Rapid release pioglitazone coatings can be scattered in pioglitazone in the Opadry coating solution, gets final product in the outer coating medicine-feeding of metformin slow release small pieces.
The advantage of slow-release micro-pill: by the slow releasing capsule that the ectonexine slow-release micro-pill is made, be characterized in that the micropill drug loading is big, can use less softgel shell, compliance is good.By the slow releasing capsule that slow-release micro-pill and fast release micropill are mixed and made into, be characterized in the convenient easily control of preparation process, two medicine proportionings can be regulated and control on demand.
The advantage of slow release small pieces: the coating individuality on size, shape and coating thickness neat and consistent, quality is even, release is constant, production technology is easy than controlled release micro pill, be easy to control qualitatively, be difficult for producing prominent releasing, can be divided into low dose clinically takes, do not influence slow release effect, convenient dose titration clinically.
Slow-release micro-pill of the present invention and slow release small pieces technology not only can effectively be controlled and delay drug release, and compare with slow releasing tablet, be difficult for producing prominent releasing, also can be divided into where necessary less than the specification metering and taking, do not influence the medicament slow release feature, can reach required effective blood drug concentration in the short time simultaneously, and can in the long time, keep required blood drug level, the bioavailability height, improved the curative effect of medicine, taking dose that has reduced every day and number of times, particularly when separately using the metformin poor blood glucose control, take slow release capsule of compound metformin pyrrolidone, useful especially glycemic control effect can be provided and not observe side effect, observed synergism is the remarkable enhancing of hypoglycemic remarkable improvement and anti-diabetic effect, reduces insulin resistant and improves dysbolism of blood fat.
When carrying out testing in vitro, the release characteristic of metformin is that release in 1～3 hour discharged 30～80% in 0～60%, 2～8 hours among the present invention, discharges more than 70% greater than 6 hours.The pioglitazone release in vitro is characterized as 5～15 minutes and discharges release 30～100% in 15～80%, 10～30 minutes, discharges more than 85% greater than 45 minutes.
Concrete technical application
(a) the slow-release pill technology prepares compound metformin hydrochloride pioglitazone hydrochloride sustained-release capsule
Embodiment 1
The compound sustained release capsules of hydrochloric metformin 250mg pioglitazone hydrochloride 7.5mg
(1) metformin hydrochloride contains the preparation of pill core
Get glyceryl monostearate 150g and be dispersed in the hot distilled water, be heated to about 80 ℃, under constant mixing speed, add the 250g metformin hydrochloride, up to forming slurry.Hot slurry was mixed 10 minutes with the 100g microcrystalline Cellulose in planetary-type mixer, then powder is squeezed into the extrudate of diameter 1mm, long 4mm with the speed of 30.0cm/min with the plunger extruder, roll in spheronizator with the 1000r/min rotating speed and promptly to get circular piller in 10 minutes, wet ball is put in the fluid bed in 40 ℃ of dryings 30 minutes, sieve at last, cut-off directly is 1.18～1.70mm person, promptly.
(2) metformin hydrochloride bag sustained-release coating layer
Above-mentioned ball core is put in the fluid bed, prepares the polymer solution spray coating by following prescription.Coating increases weight about 10%.In 40 ℃ of dryings 1 hour.
Eudragit?RS?100 5g
Eudragit?S 100 0.2g
Triethyl citrate 0.25g
Ethanol 100ml
(3) pioglitazone hydrochloride coating medicine-feeding
Get the pioglitazone hydrochloride fine powder, add while stirring in 50% alcoholic solution of 5%PVP, continue stirring and make into even suspension solution, hydrochloric pioglitazone is about 10%, above-mentioned diabecron sustained-release micropill is put in the fluid bed, and the coating weightening finish gets final product to indicating content to containing pioglitazone.40 ℃ of dryings 1 hour.
The capsule of packing into No. 0.
Embodiment 2
The compound sustained release capsules of hydrochloric metformin 425mg pioglitazone hydrochloride 7.5mg
(1) metformin hydrochloride contains the preparation of pill core
Get metformin hydrochloride 425g and mixed in planetary-type mixer 5 minutes with microcrystalline Cellulose 40g, 5%PVP is an amount of in adding, mixes 5 minutes, presses embodiment 1 operation, contains pill core with the preparation of plunger extruder.
(2) metformin hydrochloride contains pill core bag sustained-release coating layer
Above-mentioned ball core is put in the fluid bed, prepares the polymer solution spray coating by following prescription.Coating increases weight about 10%.In 40 ℃ of dryings 1 hour.
Cellulose acetate 5g
Eudragit?S?100 0.1g
Sodium chloride 0.2g
Triethyl citrate 0.25g
Ethanol 100ml
(3) pioglitazone hydrochloride coating medicine-feeding
Press embodiment 1 operation, the coating weightening finish gets final product to indicating content to containing pioglitazone.In 40 ℃ of dryings 1 hour.
The capsule of packing into No. 0.
(b) slow release small pieces technology prepares compound metformin hydrochloride pioglitazone hydrochloride sustained-release capsule
Embodiment 3
The compound sustained release capsules of hydrochloric metformin 250mg pioglitazone hydrochloride 7.5mg
(1) preparation of diabecron sustained-release small pieces
Get metformin hydrochloride 250g, hydroxypropyl emthylcellulose (beautiful how elegant K100MCR) 100g, sodium carboxymethyl cellulose 25g, microcrystalline Cellulose 20g, mix homogeneously, add the 5%PVP alcoholic solution and make granule, add 0.5% magnesium stearate after the drying, be pressed into the 3mm small pieces, every hydrochloric metformin 12.5mg, sheet heavily are 20mg.Above-mentioned small pieces are put in the fluid bed, and with following coating solution coating, the coating weightening finish is to about 7～8%.
Eudragit?RS?100 5g
Eudragit?S?100 0.1g
Triethyl citrate 0.25g
Ethanol 100ml
(2) pioglitazone hydrochloride coating medicine-feeding
Get the pioglitazone hydrochloride fine powder, add while stirring in the stomach dissolution type Opadry coating solution, continue stirring and make into even suspension solution, hydrochloric pioglitazone is about 10%, above-mentioned diabecron sustained-release small pieces are put in the fluid bed, and coating weightening finish to hydrochloric pioglitazone gets final product to indicating content.
Embodiment 4
The compound sustained release capsules of hydrochloric metformin 425mg pioglitazone hydrochloride 7.5mg
(1) preparation of diabecron sustained-release small pieces
Get metformin hydrochloride 425g and microcrystalline Cellulose 40g mix homogeneously, add the 5%PVP alcoholic solution and make granule, add 0.5% magnesium stearate after the drying, be pressed into the 5mm small pieces, every hydrochloric metformin 85mg, sheet heavily are 95mg.Above-mentioned small pieces are put in the fluid bed, and with following coating solution coating, the coating weightening finish is to about 8～9%.
Cellulose acetate 5g
Eudragit?S?100 0.1g
Sodium chloride 0.1g
Triethyl citrate 0.25g
Ethanol 100ml
(3) pioglitazone hydrochloride coating medicine-feeding
Press embodiment 3 operations, the coating weightening finish gets final product to indicating content to containing pioglitazone.
Claims (8)
1, a kind of slow release capsule of compound metformin pyrrolidone, it is characterized in that, contain the slow-release micro-pill of metformin or slow release small pieces and skin by internal layer and contain rapid release pioglitazone film-coat layer and form, wherein contain 5～60mg pioglitazone and be no more than the metformin of 3000mg.
2, slow releasing capsule as claimed in claim 1, wherein, the described rapid release pioglitazone film-coat that contains consists of: 50～99% pioglitazones; 0～40% Opadry; 0～40% binding agent.
3, slow releasing capsule as claimed in claim 1 wherein, describedly contains consisting of of metformin slow-release micro-pill or small pieces:
1. contain pill core or label: 50～98% metformin, 0～50% high molecular polymer, 0～50% organic acid or alcohol, 0.1～40% binding agent, 0～5% lubricant;
2. contain pill core or label outsourcing slow release film-coat layer: 50～99% high molecular polymers, 0～25% plasticizer, 0～25% porogen, 0～10% antiplastering aid.
4, slow releasing capsule as claimed in claim 3, wherein, 1. the high molecular polymer in is water solublity or water-insoluble macromolecular polymer or organic alcohol, fatty acid and ester thereof; 2. the high molecular polymer in is polyacrylic resin, cellulose acetate, ethyl cellulose.
5, slow releasing capsule as claimed in claim 1, wherein, metformin is metformin hydrochloride or its pharmaceutically acceptable salt.
6, slow releasing capsule as claimed in claim 1, wherein, pioglitazone is pioglitazone hydrochloride or its pharmaceutically acceptable salt.
7, slow releasing capsule as claimed in claim 1, wherein, the metformin release in vitro is characterized as 1～3 hour and discharges release 30～80% in 0～60%, 2～8 hours, discharges more than 70% greater than 6 hours.
8, slow releasing capsule as claimed in claim 1, wherein, the pioglitazone release in vitro is characterized as 5～15 minutes and discharges release 30～100% in 15～80%, 10～30 minutes, discharges more than 85% greater than 45 minutes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510014596 CN1726912A (en) | 2005-07-25 | 2005-07-25 | Slow release capsule of compound metformin pyrrolidone and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510014596 CN1726912A (en) | 2005-07-25 | 2005-07-25 | Slow release capsule of compound metformin pyrrolidone and preparation method |
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| CN1726912A true CN1726912A (en) | 2006-02-01 |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102349905A (en) * | 2011-07-28 | 2012-02-15 | 海南锦瑞制药股份有限公司 | Melbine crystal, medicinal composition of melbine crystal and pioglitazone and preparation method for medicinal composition |
| CN102525991A (en) * | 2012-02-20 | 2012-07-04 | 中国药科大学 | Compound preparation containing pioglitazone hydrochloride and metformin hydrochloride and method for preparing compound preparation containing pioglitazone hydrochloride and metformin hydrochloride |
| CN103432129A (en) * | 2013-08-26 | 2013-12-11 | 中国人民解放军第150中心医院 | Method for compounding pioglitazone hydrochloride controlled-release pellet preparation |
| CN103432128A (en) * | 2013-08-26 | 2013-12-11 | 中国人民解放军第150中心医院 | Method for compounding drug-containing layer of pioglitazone hydrochloride controlled-release pellet preparation |
| CN103446063A (en) * | 2013-08-26 | 2013-12-18 | 中国人民解放军第150中心医院 | Assembly method and preparation technology of compound metformin hydrochloride and pioglitazone hydrochloride slow-release micro-pellet preparation |
| CN103446062A (en) * | 2013-08-26 | 2013-12-18 | 中国人民解放军第150中心医院 | Preparing method of compound metformin hydrochloride and pioglitazone hydrochloride slow-release micro-pellet preparation |
| CN103462903A (en) * | 2013-08-26 | 2013-12-25 | 中国人民解放军第150中心医院 | Combination method and preparation process of pioglitazone hydrochloride sustained-release pellet preparation |
| CN104434952A (en) * | 2014-12-08 | 2015-03-25 | 成都恒瑞制药有限公司 | Pharmaceutical composition for treating diabetes and preparation method thereof |
| CN109330995A (en) * | 2018-12-05 | 2019-02-15 | 河北医科大学 | A kind of pellet and preparation method thereof containing short-acting antidiabetic drug |
| CN113398097A (en) * | 2021-07-14 | 2021-09-17 | 南京康川济医药科技有限公司 | Dapagliflozin metformin sustained release preparation and preparation method thereof |
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2005
- 2005-07-25 CN CN 200510014596 patent/CN1726912A/en active Pending
Cited By (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102349905A (en) * | 2011-07-28 | 2012-02-15 | 海南锦瑞制药股份有限公司 | Melbine crystal, medicinal composition of melbine crystal and pioglitazone and preparation method for medicinal composition |
| CN102525991A (en) * | 2012-02-20 | 2012-07-04 | 中国药科大学 | Compound preparation containing pioglitazone hydrochloride and metformin hydrochloride and method for preparing compound preparation containing pioglitazone hydrochloride and metformin hydrochloride |
| CN103462903A (en) * | 2013-08-26 | 2013-12-25 | 中国人民解放军第150中心医院 | Combination method and preparation process of pioglitazone hydrochloride sustained-release pellet preparation |
| CN103432128A (en) * | 2013-08-26 | 2013-12-11 | 中国人民解放军第150中心医院 | Method for compounding drug-containing layer of pioglitazone hydrochloride controlled-release pellet preparation |
| CN103446063A (en) * | 2013-08-26 | 2013-12-18 | 中国人民解放军第150中心医院 | Assembly method and preparation technology of compound metformin hydrochloride and pioglitazone hydrochloride slow-release micro-pellet preparation |
| CN103446062A (en) * | 2013-08-26 | 2013-12-18 | 中国人民解放军第150中心医院 | Preparing method of compound metformin hydrochloride and pioglitazone hydrochloride slow-release micro-pellet preparation |
| CN103432129A (en) * | 2013-08-26 | 2013-12-11 | 中国人民解放军第150中心医院 | Method for compounding pioglitazone hydrochloride controlled-release pellet preparation |
| CN103432128B (en) * | 2013-08-26 | 2015-11-18 | 中国人民解放军第150中心医院 | A kind of compound formulation of pioglitazone hydrochloride sustained-release pellet preparations medicated layer |
| CN103446063B (en) * | 2013-08-26 | 2016-01-20 | 崔新刚 | A kind of compound formulation of compound metformin hydrochloride pioglitazone hydrochloride sustained-release pellet preparations and preparation technology |
| CN103432129B (en) * | 2013-08-26 | 2016-01-27 | 中国人民解放军第150中心医院 | A kind of compound formulation of pioglitazone hydrochloride sustained-release pellet preparations |
| CN103462903B (en) * | 2013-08-26 | 2016-06-22 | 中国人民解放军第150中心医院 | A kind of preparation technology of pioglitazone hydrochloride sustained-release pellet preparations |
| CN104434952A (en) * | 2014-12-08 | 2015-03-25 | 成都恒瑞制药有限公司 | Pharmaceutical composition for treating diabetes and preparation method thereof |
| CN109330995A (en) * | 2018-12-05 | 2019-02-15 | 河北医科大学 | A kind of pellet and preparation method thereof containing short-acting antidiabetic drug |
| CN109330995B (en) * | 2018-12-05 | 2021-05-18 | 河北医科大学 | Pellet coated with short-acting hypoglycemic agent and preparation method thereof |
| CN113398097A (en) * | 2021-07-14 | 2021-09-17 | 南京康川济医药科技有限公司 | Dapagliflozin metformin sustained release preparation and preparation method thereof |
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