CN104473894A - Pioglitazone hydrochloride medicine-loading coating preparation and preparation method thereof - Google Patents
Pioglitazone hydrochloride medicine-loading coating preparation and preparation method thereof Download PDFInfo
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- CN104473894A CN104473894A CN201410786904.1A CN201410786904A CN104473894A CN 104473894 A CN104473894 A CN 104473894A CN 201410786904 A CN201410786904 A CN 201410786904A CN 104473894 A CN104473894 A CN 104473894A
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Abstract
The invention provides a pioglitazone hydrochloride medicine-loading coating preparation. Pioglitazone hydrochloride wraps the outer layer of a tablet core in the form of a medicine-loading coating, and has the characteristic of rapidly dissolving out active ingredients. The invention further provides a preparation method of the medicine-loading coating preparation. In the preparation method, purified water is used as a coating solvent. The pioglitazone hydrochloride medicine-loading coating preparation can be used for treating diabetes.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of pioglitazone hydrochloride medicine carrying coated preparation and preparation method thereof, described preparation can be used for the treatment of diabetes.
Background technology
Type ii diabetes, also known as non-insulin-dependent diabetes mellitus, patient does not need to rely on insulin, and orally-taken blood sugar reducing medicine can be used to control blood glucose.Current use comparatively widely oral antidiabetic drug mainly contains: 1. biguanides (as metformin) this kind of medicine has the ability reducing liver output glucose, and can help muscle cell, adipose cell and liver from blood, absorb more glucose, thus reduce blood sugar level.2. the Main Function of sulphanylureas (as glimepiride) this kind of oral antidiabetic drug stimulates the more insulins of islets of langerhans release.3. thiazolidinediones (as pioglitazone).After pioglitazone acts on the cell target location of the insulin binding site of Insulin receptor INSR, reduce insulin resistance, suppress the sugar of liver to generate, the sugar improving peripheral tissues utilizes thus reduces blood glucose.Pioglitazone usually exists with the form of pioglitazone hydrochloride in pharmaceutical preparation.
Pioglitazone hydrochloride Metformin Extended-release Tablets is developed by Japanese Takeda Pharmaceutical Company Limited, and in May, 2009 by FDA approval listing, commodity are called ACTOplus MET XR, are mainly used in the treatment of type 2 diabetes mellitus.
CN1761465B discloses a kind of pharmaceutical dosage form with the first and second active medicines, adopts the aqueous dispersion of the pioglitazone hydrochloride containing low viscous hydroxypropyl cellulose or polyvinyl alcohol-polyethyleneglycol-graft copolymer Killicoat IR to apply.Although this patent has prepared the preparation containing pioglitazone medicine carrying coatings, but the stripping of pioglitazone is slower, in stripping property test, the pioglitazone hydrochloride being no less than 50% is discharged in 15 minutes at it, described stripping property test is hydrochloric acid-potassium chloride buffer (pH2.0) medium at 37 DEG C, the 15min dissolution recorded under paddle method 50rpm is no less than 50%, the stripping result that embodiment provides is between 60.6% to 80.6%, and show until 60min in the result that embodiment 7-8 and embodiment 10-11 provides, pioglitazone hydrochloride still can not discharge completely, dissolution is up to 91.5%.
CN102008472B discloses the compound preparation of a kind of pioglitazone hydrochloride and metformin hydrochloride double-layer osmotic pump controlled-release tablet composition, wherein related to be the rapid release clothing membrane material of pioglitazone hydrochloride medicine accommodation layer be selected from hydroxypropyl methylcellulose, hydroxypropyl cellulose polyvidone, copolyvidone one or more; Its absorption enhancer be selected from Tween 80, sorbester p17, polyoxyethylene castor oil and polyoxyethylene hydrogenated Oleum Ricini one or more, wherein rapid release clothing membrane material accounts for the 30%-60% of pioglitazone hydrochloride medicine accommodation layer gross weight, absorption enhancer accounts for the 0-10% in medicine layer gross weight, this patent Example only gives hypromellose as rapid release clothing membrane material, Tween 80 as the example of absorption enhancer, and uses 80% ethanol for solvent.Although this patent can realize the Fast Stripping of pioglitazone hydrochloride, 15min dissolution is about 85-90%, and it is coating with an organic solvent, higher to equipment requirements, and the pressure of safety and environmental protection is large.
Therefore be still necessary that developing a kind of take water as the pioglitazone hydrochloride medicine carrying coating method of solvent, and the quick release of pioglitazone can be realized.
Summary of the invention
The invention provides one and prepare pioglitazone hydrochloride medicine carrying coated preparation.Described preparation can be used for the treatment of type ii diabetes, and pioglitazone hydrochloride is with the wrapped of medicine carrying coating in blank core or containing the core outer layer of active component, and this medicine carrying coated preparation can make pioglitazone hydrochloride Fast Stripping and quality controllable.
Pioglitazone hydrochloride is low-solubility high osmosis medicine, belongs to BCS II class, and its drug release rate can affect the absorption of product significantly, and then affects its curative effect.The curative effect of medicine is usually relevant to its blood drug level and area under the drug-time curve, usually find so a kind of phenomenon in clinical practice, the medicine of same dosage is for suffering from the different patients of same disease, and its curative effect often differs greatly, As the medicine took effect, the symptoms lessened for showing as of having, just right; Some curative effects are general, and the patient's condition is slightly got better and turned; And some curative effects are bad, this causes because drug-eluting speed between different medicine is different often.Particularly for BCS II class medicine, drug release is the rate-limiting step that it absorbs, and drug release rate often obtains higher blood drug level faster, produces more effective therapeutic effect; Or conversely speaking, in order to reach identical therapeutic effect, the dosage needed for the medicine that medicine discharges fast may lower than the medicine of sustained release.
Therefore, the present invention provide firstly a kind of medicine carrying coated preparation that pioglitazone hydrochloride can be made to discharge fast, containing low viscous water soluble film-forming material and nonionic surfactant.
According to pioglitazone hydrochloride medicine carrying coated preparation of the present invention, adopt paddle method 50rpm to measure, in the pH2.0 hydrochloric acid-potassium chloride buffer of 900mL, 15min dissolution is not less than 85%.
Preferably, according to pioglitazone hydrochloride medicine carrying coated preparation of the present invention, in employing, method measures 10min dissolution and is not less than 85%.
According to embodiment of the present invention, low viscous water soluble film-forming material is selected from low viscous hypromellose, hyprolose, copolyvidone; Be preferably low viscous hypromellose, copolyvidone; Be more preferably the hypromellose indicating viscosity 2-6cP.
Inventor finds under study for action, even if select low viscous filmogen, too high consumption also can hinder the quick release of medicine, such as, when other factors are identical, when filmogen consumption is respectively 1:1 or 1:3, the drug release rate of the latter is obviously faster than the former.
On the other hand, too low filmogen consumption can cause the bonding force between medicine and label not enough, and medicine can not effectively stick to sheet wicking surface, causes drug loss, and causes coated tablet outward appearance bad.Research finds, under suitable composition and technology controlling and process, when the amount ratio of filmogen and medicine is 1:16, still can obtain satisfied coating efficiency and qualified product.
Therefore, according to embodiment of the present invention, the ratio of low viscous water soluble film-forming material consumption and pioglitazone hydrochloride consumption is between 1:3 to 1:16(weight: weight) between; Be preferably 1:3 to 1:8.
According to the preferred embodiments of the invention, low viscosity water soluble film-forming material is the hypromellose indicating viscosity 2-6cP, and the ratio of its consumption and pioglitazone hydrochloride consumption is 1:3 to 1:8.
Under normal circumstances, surfactant can promote the release of insoluble drug, but in medicine carrying coated preparation, the selection of surfactant is not arbitrary, inventor finds under study for action, micronized pioglitazone hydrochloride is scattered in the aqueous medium containing sodium lauryl sulphate (SDS), Keep agitation keeps its suspension, medicine crystal can increase gradually, such as in stirring after 4 hours, suspension is crossed 60 mesh sieves, will find screen cloth remains medicine crystal, this is due in dispersion, there is the balance of dissolving and separating out in pioglitazone hydrochloride, medicine is separated out at larger plane of crystal gradually, crystal is increased gradually.This situation can cause the exception of medicine carrying coating, and such as spray gun is blocked by crystal, and makes drug-eluting slack-off.For laboratory research, because coating batch is less, the time that coating continues is short, and this phenomenon possibility is also not obvious; But in commercially producing, because production lot increases, the time needed for medicine carrying coating is longer, and what this phenomenon will be serious affects carrying out smoothly of art for coating, and affects product quality.
Inventor is by a large amount of experimental studies, find with nonionic surfactant, particularly gather hydroxyl oxygen ester with Oleum Ricini, castor oil hydrogenated gathers hydroxyl oxygen ester, or polyglycol distearate is when being surfactant, can obtain stable dispersion in larger concentration range, even if Keep agitation 24 hours, pioglitazone hydrochloride crystal also can not significantly increase.According to the present invention, the consumption of nonionic surfactant accounts for 0.1% to 5% of medicine carrying coating dispersion; Preferably 0.5% to 2.5%.
According to the preferred embodiments of the invention, pioglitazone hydrochloride is through micronized, and preferred mean diameter is no more than the pioglitazone hydrochloride of 20 μm, is more preferably the pioglitazone hydrochloride that mean diameter is no more than 10 μm.
According to the present invention, pioglitazone hydrochloride medicine carrying coated preparation can be wrapped in blank wicking surface, be prepared into folk prescription tablet, also can be wrapped in pastille wicking surface, be prepared into the compound preparation containing pioglitazone hydrochloride, according to the present invention, pastille label refers to can combine rapid release for the medicine for the treatment of diabetes or slow release label containing pharmacy effective dose with pioglitazone hydrochloride.Such as be wrapped in metformin hydrochloride osmotic pump type slow releasing tablet surface, be prepared into pioglitazone hydrochloride rapid release, the compound tablet of diabecron sustained-release.
Present invention also offers the preparation method of described pioglitazone hydrochloride medicine carrying coated preparation, concrete, low viscous water soluble film-forming material and nonionic surfactant are dissolved in appropriate purified water, add pioglitazone hydrochloride, stirring makes it fully disperse, coating dispersion even spraying is also dry to sheet wicking surface, until reach theoretical coating weight gain.
Preparation in accordance with the present invention, the concentration of coating dispersion is 5-20%, and preferred 5-15%, is more preferably 8-12%.The concentration of coating dispersion affects the viscosity of coating solution, Coating times, coating uniformity, and coating outward appearance, and too high concentration can cause coating uniformity poor, the out-of-flatness of coating outward appearance; And too low concentration can make Coating times extend, the energy resource consumption needed for drying is comparatively large, is unfavorable for reducing production cost, enhances productivity.
Preparation in accordance with the present invention, described label can be blank label, also can be the label containing medicine, first-selected containing pharmacy effective dose can with the label of the medicine of pioglitazone hydrochloride use in conjunction, the label of the metformin hydrochloride particularly containing pharmacy effective dose.
According to the present invention, described blank label or pastille label can adopt method preparation disclosed in prior art arbitrarily, below provide some typical preparation methoies as a reference.
Reference example 1: by mono-for 700g water and milk sugar and 290g microcrystalline Cellulose mix homogeneously, add the mixing of 10g magnesium stearate, tabletting is to obtain the blank of the heavy 500mg of sheet.
Reference example 2: micronized for 1000g metformin hydrochloride and 50g hypromellose are put in wet mixing pelletizer granulator, add 80% ethanol water to granulate, fluid bed drying, adds the mixing of 20g magnesium stearate, obtains label by the heavy 1070mg tabletting of theoretical sheet; 90g cellulose acetate and 10g Polyethylene Glycol are dissolved in the aqueous acetone solution of 90%, and are evenly coated to sheet wicking surface, make a call to an aperture with laser-beam drilling machine is each on slice, thin piece two sides, the diabecron sustained-release tablet label of obtained 1000mg specification.
Reference example 3: micronized for 1000g metformin hydrochloride and 30g polyvinyl alcohol are put in wet mixing pelletizer granulator, the aqueous solution adding 10g polyvidone is granulated, fluid bed drying, adds the mixing of 20g magnesium stearate, obtains label by the heavy 1070mg tabletting of theoretical sheet; 95g cellulose acetate and 5g Polyethylene Glycol are dissolved in the aqueous acetone solution of 90%, and are evenly coated to sheet wicking surface, make a call to an aperture with laser-beam drilling machine is each on slice, thin piece two sides, the diabecron sustained-release tablet label of obtained 1000mg specification.
Reference example 4: by micronized for 500g metformin hydrochloride and the mixing of 80g polyvinyl alcohol, the aqueous solution adding 10g polyvidone is granulated, and adds the mixing of 10g magnesium stearate, obtains medicated layer and mix granule; By 250g polyvinyl alcohol, 100 sodium chloride, 2g red ferric oxide mixes, and the aqueous solution adding 8g polyvidone is granulated, fluid bed drying, adds the mixing of 5g magnesium stearate, obtains boosting layer granule; Medicated layer granule and boosting layer granule are pressed into double-layer tablet; 95g cellulose acetate and 5g Polyethylene Glycol are dissolved in the aqueous acetone solution of 90%, and are evenly coated to sheet wicking surface, make a call to an aperture with laser-beam drilling machine in medicated layer side, the diabecron sustained-release tablet label of obtained 500mg specification.
Reference example 5: by micronized for 500g metformin hydrochloride, 200mg microcrystalline Cellulose, 60g cross-linking sodium carboxymethyl cellulose, 30g polyvidone mix homogeneously, add purified water to granulate, fluid bed drying, add the mixing of 10g magnesium stearate, by the heavy 800mg tabletting of theoretical sheet, obtain the metformin hydrochloride tablet label of 500mg specification.
accompanying drawing illustrates:
The pioglitazone stripping curve of Fig. 1, embodiment 1-7 sample.
Detailed description of the invention
Below by way of specific embodiment, the invention will be further described, but these embodiments do not mean that any limitation of the invention.
Embodiment 1
Component | Monolithic consumption/mg | Ratio/% |
Pioglitazone hydrochloride | 33 | 4.9 |
Copolyvidone | 11 | 1.6 |
Oleum Ricini gathers hydroxyl oxygen ester (Cremophor EL) | 10 | 1.5 |
Purified water | 621 | 92.0 |
Illustrate: 33mg pioglitazone hydrochloride is equivalent to 30mg pioglitazone.
Copolyvidone, Cremophor EL are dissolved in purified water, add micronized pioglitazone hydrochloride, stir and make it fully disperse; Set high by blank label in effect seed-coating machine, control strip bed tempertaure is about 35 DEG C-45 DEG C, sprays with above-mentioned dispersion liquid and drying, until obtain the coating weight gain of target, obtains the Rates of Pioglitazone Hydrochloride Tablets Preparation of 30mg specification.
Embodiment 2
Component | Monolithic consumption/mg | Ratio/% |
Pioglitazone hydrochloride | 33 | 8.9 |
Copolyvidone | 4.1 | 1.1 |
Oleum Ricini gathers hydroxyl oxygen ester (Cremophor EL) | 7.4 | 2.0 |
Purified water | 326 | 88.0 |
Adopt the technical process that embodiment 1 is similar, coating dispersion is evenly coated on the diabecron sustained-release tablet label of 1000mg specification, obtains the pioglitazone hydrochloride Metformin Extended-release Tablets of 30/1000mg.
Embodiment 3
Component | Monolithic consumption/mg | Ratio/% |
Pioglitazone hydrochloride | 33 | 6.0 |
Hypromellose (Methocel VLV) | 3.7 | 0.7 |
Castor oil hydrogenated gathers hydroxyl oxygen ester (Cremophor RH40) | 7.3 | 1.3 |
Purified water | 506 | 92.0 |
Adopt the technical process that embodiment 1 is similar, coating dispersion is evenly coated on the diabecron sustained-release tablet label of 1000mg specification, obtains the pioglitazone hydrochloride Metformin Extended-release Tablets of 30/1000mg.
Embodiment 4
Component | Monolithic consumption/mg | Ratio/% |
Pioglitazone hydrochloride | 33 | 8.8 |
Hypromellose (Methocel E5) | 2.75 | 0.7 |
Castor oil hydrogenated gathers hydroxyl oxygen ester (Cremophor RH40) | 1.95 | 0.5 |
Purified water | 339.3 | 90.0 |
Adopt the technical process that embodiment 1 is similar, coating dispersion is evenly coated on the diabecron sustained-release tablet label of 1000mg specification, obtains the pioglitazone hydrochloride Metformin Extended-release Tablets of 30/1000mg.
Embodiment 5
Component | Monolithic consumption/mg | Ratio/% |
Pioglitazone hydrochloride | 33 | 14.0 |
Hyprolose (HPC-L) | 2.06 | 0.9 |
Polyglycol distearate (Solutol HS 15) | 11.94 | 5.1 |
Purified water | 188 | 80.0 |
Adopt the technical process that embodiment 1 is similar, coating dispersion is evenly coated on the diabecron sustained-release tablet label of 1000mg specification, obtains the pioglitazone hydrochloride Metformin Extended-release Tablets of 30/1000mg.
Embodiment 6
Component | Monolithic consumption/mg | Ratio/% |
Pioglitazone hydrochloride | 16.5 | 2.0 |
Hyprolose (HPC-SSL) | 4.1 | 0.5 |
Polyglycol distearate (Solutol HS 15) | 20.4 | 2.5 |
Purified water | 779 | 95.0 |
Adopt the technical process that embodiment 1 is similar, coating dispersion is evenly coated on the diabecron sustained-release tablet label of 1000mg specification, obtains the pioglitazone hydrochloride Metformin Extended-release Tablets of 15/1000mg.
Embodiment 7
Component | Monolithic consumption/mg | Ratio/% |
Pioglitazone hydrochloride | 16.5 | 11.2 |
Hypromellose (Methocel E5) | 5.5 | 3.7 |
Polyglycol distearate (Cremophor RH40) | 0.2 | 0.1 |
Purified water | 125.8 | 85.0 |
Adopt the technical process that embodiment 1 is similar, coating dispersion is evenly coated on the diabecron sustained-release tablet label of 1000mg specification, obtains the pioglitazone hydrochloride Metformin Extended-release Tablets of 15/1000mg.
According to Chinese Pharmacopoeia 2010 editions dissolution method second methods (paddle method), in the pH2.0 chlorination of hydrochloric acid potassium buffer of 900mL, measure the pioglitazone stripping curve of embodiment 1-7,15min dissolution is not less than 85%.
Claims (12)
1. a pioglitazone hydrochloride medicine carrying coated preparation, the pioglitazone hydrochloride containing pharmacy effective dose, low viscous water soluble film-forming material, and nonionic surfactant, is characterized in that:
1) low viscous water soluble film-forming material is selected from copolyvidone, low viscous hyprolose or hypromellose, and the ratio of low viscous water soluble film-forming material consumption and pioglitazone hydrochloride consumption is 1:3 to 1:16;
2) nonionic surfactant is selected from Oleum Ricini and gathers hydroxyl oxygen ester, and castor oil hydrogenated gathers hydroxyl oxygen ester, or polyglycol distearate, and its consumption accounts for 0.1% to 5% of medicine carrying coating dispersion;
3) medicine carrying coating process is using purified water as solvent.
2. pioglitazone hydrochloride medicine carrying coated preparation according to claim 1, it is characterized in that low viscous water soluble film-forming material is selected from sign viscosity is the hypromellose of 2-6cP.
3. pioglitazone hydrochloride medicine carrying coated preparation according to claim 1, is characterized in that the ratio of low viscous water soluble film-forming material consumption and pioglitazone hydrochloride consumption is 1:3 to 1:8.
4. pioglitazone hydrochloride medicine carrying coated preparation according to claim 1, is characterized in that nonionic surfactant is selected from polyglycol distearate.
5. pioglitazone hydrochloride medicine carrying coated preparation according to claim 1, is characterized in that the consumption of nonionic surfactant accounts for 0.5% to 2.5% of medicine carrying coating dispersion.
6. pioglitazone hydrochloride medicine carrying coated preparation according to claim 1, is characterized in that the mean diameter of pioglitazone hydrochloride is no more than 20 μm.
7. pioglitazone hydrochloride medicine carrying coated preparation according to claim 6, is characterized in that the mean diameter of pioglitazone hydrochloride is no more than 10 μm.
8. pioglitazone hydrochloride medicine carrying coated preparation according to claim 1, pioglitazone hydrochloride medicine carrying coatings can be wrapped in blank wicking surface, or pastille wicking surface, described pastille label refers to can combine rapid release for the medicine for the treatment of diabetes or slow release label containing pharmacy effective dose with pioglitazone hydrochloride.
9. pioglitazone hydrochloride medicine carrying coated preparation according to claim 9, is characterized in that pioglitazone hydrochloride medicine carrying coatings is wrapped in diabecron sustained-release tablet sheet wicking surface.
10. a preparation method for the medicine carrying coated preparation as described in claim 1 or 9, comprises the following steps:
1) low viscous water soluble film-forming material and nonionic surfactant are dissolved in appropriate purified water, add pioglitazone hydrochloride, stir and make it fully disperse to obtain medicine carrying coating dispersion;
2) by the diabecron sustained-release tablet sheet wicking surface of medicine carrying coating dispersion even spraying to preheating, and fully dry, until reach the weightening finish of target.
11. preparation methoies according to claim 10, is characterized in that the concentration of medicine carrying coating dispersion is 5-20%.
12. preparation methoies according to claim 11, is characterized in that the concentration of medicine carrying coating dispersion is 8-12%.
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN109010298A (en) * | 2018-08-31 | 2018-12-18 | 迪沙药业集团有限公司 | A kind of melbine glipizide compound and preparation method thereof |
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CN101623274A (en) * | 2002-09-20 | 2010-01-13 | 华生制药公司 | Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
CN102008472A (en) * | 2010-10-18 | 2011-04-13 | 中国科学院上海药物研究所 | Compound pioglitazone hydrochloride/metformin hydrochloride bilayer osmotic pump controlled release preparation and preparation method thereof |
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 |
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CN101623274A (en) * | 2002-09-20 | 2010-01-13 | 华生制药公司 | Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
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CN1852703A (en) * | 2003-09-19 | 2006-10-25 | 安壮奇实验室公司 | Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
CN102008472A (en) * | 2010-10-18 | 2011-04-13 | 中国科学院上海药物研究所 | Compound pioglitazone hydrochloride/metformin hydrochloride bilayer osmotic pump controlled release preparation and preparation method thereof |
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