CN102362863B - Orlistat-containing preparation and preparation method thereof - Google Patents
Orlistat-containing preparation and preparation method thereof Download PDFInfo
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- CN102362863B CN102362863B CN 201110370659 CN201110370659A CN102362863B CN 102362863 B CN102362863 B CN 102362863B CN 201110370659 CN201110370659 CN 201110370659 CN 201110370659 A CN201110370659 A CN 201110370659A CN 102362863 B CN102362863 B CN 102362863B
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Abstract
The invention relates to an Orlistat-containing preparation and a preparation method thereof. The preparation contains an Orlistat coating layer, and is prepared after forming the Orlistat coating layer by coating surface of a blank tablet or blank pill with molten Orlistat. When the preparation method provided by the invention is used to prepare the Orlistat preparation, the sticking and picking problem aroused by melting of Orlistat in a production process can be effectively solved, and at the same time, the preparation retains high stability and dissolution rate.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of preparation that contains orlistat and preparation method thereof.
Background technology
The chemical name of orlistat: N-formyl-L-Leu (s)-1[(2s, 3s) 3-hexyl-4 oxygen base-2-glycidyl methyl] ten diester, also claim ORLISTAT (THL), be a kind of semisynthetic lipstatin derivant, structural formula is as follows:
orlistat is that a kind of white is to the crystallinity powder of off-white color, it is a kind of liposoluble substance, dissolubility in the water of physiological pH is very low, it is a kind of lipase inhibitor, because it has lower fusing point, about 44 ℃, can be because of hydrolysis or hot the degraded, particularly be stored in malaria or the humid air more than 65 ℃, it has various lipases such as lipoprotein lipase in external interior all resisting, the activity of the synzyme of pancreas triglycerides lipase and fatty acid, make the free fatty acid that can not be hydrolyzed into easy absorption from triglyceride in diet, thereby it is not absorbed and excretes external.
The Alli of the prescription drugs Xenical that contains principal agent 120mg that the present slimming medicine that goes on the market take orlistat as main active is Luo Shi and the nonprescription drugs that contains principal agent 60mg of GlaxoSmithKline PLC.
US6004996 discloses a kind of preparation method of orlistat preparation, that active fraction preparation is become in the hard capsules of packing into after piller to form, active component comprising 50%, adjuvant is mainly as diluent and extrudes round as a ball microcrystalline Cellulose, make the sodium lauryl sulphate of solubilizing agent, as the PVP K30 of binding agent and the Pulvis Talci that is used as lubricant, be prepared into the 0.25-2mm piller with extruder, the hard capsules of then packing into.But find in test: if piller hardness is large, drug-eluting is relatively poor; If piller hardness is little, frangible in the capsule charge process, heat production during production in enormous quantities causes piller surface orlistat thawing, and then the sticking bar, makes to produce to be difficult to carry out smoothly.
W02009050720 discloses the pharmaceutical composition of the water-soluble polymer carrier of a kind of stable orlistat that contains 20-60% and 40-80%, water-solubility carrier is selected from hydroxypropyl methylcellulose, methylcellulose, hydroxypropyl cellulose, increase the dissolution of orlistat, improved the bioavailability of orlistat.Adopt fluid unit, preparation process is as follows:
(a) preparation contains the aqueous solution of the water soluble polymer material of surfactant.
(b) the orlistat powder is dispersed in this solution.
(c) the orlistat suspension is sprayed on pharmaceutically acceptable pharmaceutic adjuvant surface, is processed at last dosage form.
But, this suspension is sprayed in the process on graininess adjuvant surface, orlistat raw material surface that can not be all is aggregated thing and coats, and will inevitably some orlistat be attached to the outer surface at granule, equally can be because of drift heating sticking in the tabletting process.Be water owing to adopting solvent simultaneously, baking temperature is low again, and dry run is longer.
US7393545 discloses a kind of soluble fiber element sheet of lipase inhibitor, adopted a large amount of methylcellulose as carrier, cause sheet heavy very large, increased patient's medication difficulty, if take after dissolving, mouthfeel is bad again, does not fundamentally solve sticking problem in the tabletting process, just weigh by increasing sheet, reduced the content of orlistat.
Summary of the invention
In view of the deficiencies in the prior art, the object of the invention is to further investigate by physicochemical properties and preparation thereof to orlistat, a kind of novel orlistat preparation and preparation method thereof is provided.The orlistat preparation that the present invention is prepared efficiently solves the sticking problem that causes because of the orlistat thawing in production process, and preparation has kept stability and dissolution preferably simultaneously.
The object of the present invention is achieved like this:
A kind of preparation that contains orlistat contains the orlistat coatings, and described preparation is by with the orlistat fused solution, and coating is prepared from after blank or blank piller surface form described orlistat coatings.
The described preparation that contains orlistat, wherein said blank or blank piller comprise filler, disintegrating agent and lubricant.
The described preparation that contains orlistat, wherein said blank or blank piller comprise filler, disintegrating agent, binding agent and lubricant.
The described preparation that contains orlistat, wherein said filler are selected from following one or more: starch, lactose, Icing Sugar, mannitol, dextrin, cyclodextrin, microcrystalline Cellulose and sucrose; Described disintegrating agent is selected from following one or more: carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, pregelatinized Starch and low-substituted hydroxypropyl cellulose; Described lubricant is selected from following one or more: magnesium stearate, Pulvis Talci and micropowder silica gel.
The described preparation that contains orlistat, wherein said orlistat coatings is surrounded by the gastric solubleness film-coat outward.
A kind of preparation method of orlistat preparation comprises the following steps:
(1) after the heating orlistat becomes oily, keep the fused solution temperature between 40-60 ℃;
(2) with the orlistat fused solution, blank or piller are carried out coating.
A kind of preparation method of orlistat preparation, the heating orlistat makes thawing, pass through coating, orlistat is wrapped in piller or sheet sub-surface, because do not add entry or organic solvent, the coating temperature is during lower than 40 ℃, and orlistat just can solidify and be attached to slice, thin piece or piller surface, so the coating process need not heating.
Preferably, the preparation method of described orlistat preparation wherein adopts the gastric solubleness coating solution to carry out coating again.
Compared with prior art, orlistat preparation that the present invention relates to and preparation method thereof has following advantage and significant progressive:
(1) a kind of orlistat preparation of the present invention, the unfavorable factor in the preparation process of having avoided causing because fusing point is too low due to orlistat can be prepared into the various dosage forms of pharmaceutically commonly using.
(2) after coating of the present invention, tablet, piller can directly be packed, perhaps continue at surperficial film coating, preventing the thawing that rubs of piller surface orlistat in the filling process, so the present invention efficiently solves the thawing of orlistat in production process and the sticking problem that causes.
(3) a kind of orlistat preparation of the present invention because orlistat is evenly distributed on dosage surface, is conducive to the Fast Stripping of orlistat in gastrointestinal tract body fluid.In addition, the good stability of orlistat preparation.
(4) a kind of orlistat preparation of the present invention, its preparation process is fairly simple, and is easy to operate, is fit to industrialized great production.
The specific embodiment
Now further describe beneficial effect of the present invention by following examples, embodiment only is used for the purpose of illustration, do not limit the scope of the invention, within the apparent change that while those of ordinary skills make according to the present invention and modification are also contained in the scope of the invention.
Embodiment 1 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, lactose, carboxymethyl starch sodium, magnesium stearate mix homogeneously, tabletting gets blank;
50 ℃ of heat fused of orlistat with fused solution coating on blank, and get final product.
Embodiment 2 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, starch, carboxymethyl starch sodium, magnesium stearate mix homogeneously, tabletting gets blank;
45 ℃ of heat fused of orlistat with fused solution coating on blank, obtain containing tablet;
To contain tablet bag gastric solubleness clothing, and get final product.
Embodiment 3 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, starch, carboxymethyl starch sodium, magnesium stearate mix homogeneously add 2% PVP K30 aqueous solution appropriate, granulate, and tabletting gets blank;
60 ℃ of heat fused of orlistat with fused solution coating on blank, obtain containing tablet;
To contain tablet bag gastric solubleness clothing, and get final product.
Embodiment 4 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, carboxymethyl starch sodium mix homogeneously add 2% PVP K30 aqueous solution appropriate, and extrusion granulator is round as a ball, gets blank piller;
50 ℃ of heat fused of orlistat with fused solution coating on blank piller, obtain the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, and get final product.
Embodiment 5 (10000)
Starch piller 3000g
Orlistat 1200g
Gastric solubleness coating solution weightening finish 2%
Preparation technology:
60 ℃ of heat fused of orlistat with fused solution coating on the starch piller, obtain the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, and get final product.
Embodiment 6 (10000)
Microcrystalline Cellulose piller 4000g
Orlistat 1200g
Gastric solubleness coating solution weightening finish 2%
Preparation technology:
55 ℃ of heat fused of orlistat with fused solution coating on the microcrystalline Cellulose piller, obtain the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, and get final product.
Embodiment 7 (10000)
Nonpareils 4000g
Orlistat 1200g
Gastric solubleness coating solution weightening finish 2%
Preparation technology:
60 ℃ of heat fused of orlistat with fused solution coating on nonpareils, obtain the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, and get final product.
Comparative example 1 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, lactose, carboxymethyl starch sodium, orlistat, magnesium stearate mix homogeneously, tabletting, and get final product.
Comparative example 2 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, lactose, carboxymethyl starch sodium, orlistat, magnesium stearate mix homogeneously, tabletting, and get final product.
Comparative example 3 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, carboxymethyl starch sodium, orlistat mix homogeneously add 2% PVP K30 aqueous solution appropriate, extrusion granulator, and round as a ball, drying obtains the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, and get final product.
Comparative example 4 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, carboxymethyl starch sodium, orlistat mix homogeneously add entry appropriate, and extrusion granulator is round as a ball, and drying obtains the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, and get final product.
Comparative example 5 (10000)
Nonpareils 4000g
Orlistat 1200g
Preparation technology:
60 ℃ of heat fused of orlistat with fused solution coating on nonpareils, obtain the pastille piller;
With the pastille piller, incapsulate, and get final product.
Stability and the dissolution determination of embodiment 8 orlistat preparations
Dissolution is got this product, according to dissolution method (two appendix XC the second methods of Chinese Pharmacopoeia version in 2010), 1000ml is dissolution medium with pH6.0 buffer (get sodium lauryl sulphate 30g and sodium chloride 5g, add water 1000ml dissolving, and regulate pH value to 6.0 with phosphoric acid), rotating speed is per minute 75 to turn, operation, in the time of 45 minutes, get solution appropriate in accordance with the law, filter, get subsequent filtrate as need testing solution; Separately get the orlistat reference substance appropriate, accurately weighed, add acetonitrile and make in right amount dissolving, quantitatively dilute with dissolution medium and make the solution that approximately contains 0.12mg in every 1ml, product solution in contrast.According to the chromatographic condition under the assay item, precision measures need testing solution and each 20 μ l of reference substance solution, and the injection liquid chromatography, record chromatogram respectively.By the stripping quantity of external standard method with every of calculated by peak area.Limit is 75% of labelled amount, should be up to specification.
Related substance is got this product fine powder appropriate (approximately being equivalent to orlistat 25mg), and is accurately weighed, puts in the 50ml measuring bottle, adds the mobile phase ultrasonic dissolution and is diluted to scale, shakes up, and puts in the glass centrifuge tube centrifugally, gets supernatant as need testing solution; Precision measures 1ml, puts in the 100ml measuring bottle, adds mobile phase and is diluted to scale, shakes up, in contrast solution.According to the chromatographic condition under the assay item, get contrast solution 20 μ l injection liquid chromatographies, regulate detection sensitivity, the peak height that makes the main constituent chromatographic peak is 10%～20% of full scale.Precision measures each 20 μ l of need testing solution and contrast solution again, and injection liquid chromatography respectively records chromatogram to 5 times of main constituent peak retention time.In the chromatogram of need testing solution if any impurity peaks (deduction adjuvant peak), single impurity peak area must not be greater than 0.2 times (0.2%) of contrast solution main peak peak area, each impurity peak area and must not be greater than 3 times (3.0%) of contrast solution main peak peak area.
Stability and the dissolution of the orlistat preparation of each embodiment preparation of table 1
| Visual examination | Related substance (single assorted) | Dissolution | |
| Embodiment 1 | The off-white color sheet is unilateral bright and clean | Related substance 0.12% | 94.2-99.1％ |
| Embodiment 2 | The off-white color sheet is unilateral bright and clean | Related substance 0.13% | 94.5-98.2％ |
| Embodiment 3 | The off-white color sheet is unilateral bright and clean | Related substance 0.14% | 92.3-97.8％ |
| Embodiment 4 | The off-white color piller, smooth surface | Related substance 0.12% | 94.5-95.2％ |
| Embodiment 5 | The off-white color piller, smooth surface | Related substance 0.12% | 93.4-99.2％ |
| Embodiment 6 | The off-white color piller, smooth surface | Related substance 0.13% | 94.5-95.2％ |
| Embodiment 7 | The off-white color piller, smooth surface | Related substance 0.14% | 95.5-98.7％ |
| The comparative example 1 | The off-white color sheet, sticking, unilateral have a piebaldism | Related substance 0.12% | 81.2-86.7％ |
| The comparative example 2 | The off-white color sheet, sticking, unilateral have a piebaldism | Related substance 0.13% | 82.7-88.8％ |
| The comparative example 3 | The off-white color piller has melting phenomenon | Related substance 0.12% | 83.6-90.5％ |
| The comparative example 4 | The off-white color piller has melting phenomenon | Related substance 0.14% | 80.5-85.6％ |
| The comparative example 5 | The off-white color piller has melting phenomenon | Related substance 0.14% | 95.5-98.7％ |
Find out from comparing result: the orlistat preparation of embodiment of the present invention 1-3 preparation is unilateral smooth, embodiment 4-7 piller smooth surface, and related substance is less, and stripping is complete;
Comparative example 1-4, although related substance is little, dissolution is relatively poor, and the orlistat of comparative example 1-2 preparation is unilateral that piebaldism arranged, sticking, there is melting phenomenon on comparative example 3-4 orlistat piller surface;
The comparative example 5, although related substance is little, stripping is complete, and there is melting phenomenon on the piller surface.
This shows, the prepared tablet of the present invention is unilateral bright and clean, the piller smooth surface, and stripping is rapid, has compared with prior art obtained significant technique effect.
Claims (1)
1. preparation that contains orlistat is characterized in that: contain the orlistat coatings, described preparation is by with the orlistat fused solution, and coating is prepared from after blank or blank piller surface form described orlistat coatings; Described blank or blank piller comprise filler, disintegrating agent and lubricant.
2, the preparation that contains orlistat according to claim 1 is characterized in that: described blank or blank piller comprise filler, disintegrating agent, binding agent and lubricant.
3, the preparation that contains orlistat according to claim 1 and 2 is characterized in that: described filler is selected from following one or more: starch, lactose, Icing Sugar, mannitol, dextrin, cyclodextrin, microcrystalline Cellulose and sucrose; Described disintegrating agent is selected from following one or more: carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, pregelatinized Starch and low-substituted hydroxypropyl cellulose; Described lubricant is selected from following one or more: magnesium stearate, Pulvis Talci and micropowder silica gel.
4, the preparation that contains orlistat according to claim 1 and 2 is characterized in that: described orlistat coatings is surrounded by the gastric solubleness film-coat outward.
5, the preparation that contains orlistat according to claim 3 is characterized in that: described orlistat coatings is surrounded by the gastric solubleness film-coat outward.
6, a kind of preparation method of orlistat preparation comprises the following steps:
(1) after the heating orlistat becomes oily, keep the fused solution temperature between 40-60 ℃;
(2) with the orlistat fused solution, blank or piller are carried out coating;
(3) adopt the gastric solubleness coating solution to carry out coating.
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| CN 201110370659 CN102362863B (en) | 2011-11-21 | 2011-11-21 | Orlistat-containing preparation and preparation method thereof |
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| CN103393608B (en) * | 2013-08-13 | 2015-09-16 | 杭州高成生物营养技术有限公司 | A kind of Cetilistat micropill and preparation method thereof |
| CN106822020A (en) * | 2017-02-21 | 2017-06-13 | 鲁南制药集团股份有限公司 | A kind of Ezetimibe tablet |
| CN106727398B (en) * | 2017-02-21 | 2018-12-28 | 鲁南制药集团股份有限公司 | A kind of simvastatin tablet |
| CN106983723B (en) * | 2017-05-08 | 2018-08-21 | 重庆植恩药业有限公司 | Orlistat liposome and preparation method thereof and the application in antitumor drug |
| CN111297826B (en) * | 2020-04-20 | 2021-08-03 | 鲁南制药集团股份有限公司 | Stable orlistat capsule and preparation method thereof |
| CN114767634A (en) * | 2022-03-14 | 2022-07-22 | 大邦(湖南)生物制药有限公司 | Orlistat pellet, preparation method thereof and orlistat capsule |
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| US6004996A (en) * | 1997-02-05 | 1999-12-21 | Hoffman-La Roche Inc. | Tetrahydrolipstatin containing compositions |
| CN1582169A (en) * | 2001-10-30 | 2005-02-16 | 德古萨股份公司 | Use of granular materials based on pyrogenically produced silicon dioxide in pharmaceutical compositions |
| CN1625390A (en) * | 2002-02-01 | 2005-06-08 | 株式会社太平洋 | Multi-stage oral drug controlled-release system |
| US7393545B2 (en) * | 1998-09-08 | 2008-07-01 | Smithkline Beecham Corporation | Lipstatin derivative—soluble fiber tablets |
| CN101237891A (en) * | 2005-08-17 | 2008-08-06 | 普览制药株式会社 | Pharmaceutical formulation with high stability and dissolution and manufacturing process |
| WO2009050720A1 (en) * | 2007-10-15 | 2009-04-23 | Inventis Dds Pvt Limited | Pharmaceutical composition of orlistat |
| WO2010084502A1 (en) * | 2009-01-22 | 2010-07-29 | Biocon Limited | A crystalline form of orlistat and a process thereof |
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2011
- 2011-11-21 CN CN 201110370659 patent/CN102362863B/en active Active
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6004996A (en) * | 1997-02-05 | 1999-12-21 | Hoffman-La Roche Inc. | Tetrahydrolipstatin containing compositions |
| US7393545B2 (en) * | 1998-09-08 | 2008-07-01 | Smithkline Beecham Corporation | Lipstatin derivative—soluble fiber tablets |
| CN1582169A (en) * | 2001-10-30 | 2005-02-16 | 德古萨股份公司 | Use of granular materials based on pyrogenically produced silicon dioxide in pharmaceutical compositions |
| CN1625390A (en) * | 2002-02-01 | 2005-06-08 | 株式会社太平洋 | Multi-stage oral drug controlled-release system |
| CN101237891A (en) * | 2005-08-17 | 2008-08-06 | 普览制药株式会社 | Pharmaceutical formulation with high stability and dissolution and manufacturing process |
| WO2009050720A1 (en) * | 2007-10-15 | 2009-04-23 | Inventis Dds Pvt Limited | Pharmaceutical composition of orlistat |
| WO2010084502A1 (en) * | 2009-01-22 | 2010-07-29 | Biocon Limited | A crystalline form of orlistat and a process thereof |
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Inventor after: Zhang Guimin Inventor after: Zhao Zhiquan Inventor after: Hao Guizhou Inventor after: Feng Zhong Inventor before: Zhao Zhiquan Inventor before: Hao Guizhou Inventor before: Feng Zhong |
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Free format text: CORRECT: INVENTOR; FROM: ZHAO ZHIQUAN HAO GUIZHOU FENG ZHONG TO: ZHANG GUIMIN ZHAO ZHIQUAN HAO GUIZHOU FENG ZHONG |