CN103099796B - Propylene glycol marinate sulfate-containing sustained-release preparation and preparation method thereof - Google Patents
Propylene glycol marinate sulfate-containing sustained-release preparation and preparation method thereof Download PDFInfo
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- CN103099796B CN103099796B CN201310053630.0A CN201310053630A CN103099796B CN 103099796 B CN103099796 B CN 103099796B CN 201310053630 A CN201310053630 A CN 201310053630A CN 103099796 B CN103099796 B CN 103099796B
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Abstract
The invention discloses a propylene glycol marinate sulfate sustained-release preparation and a preparation method thereof. The propylene glycol marinate sulfate sustained-release preparation comprises: propylene glycol marinate sulfate, a sustained-release skeleton matrix, a filler, a surfactant, a lubricant and a binder. The propylene glycol marinate sulfate sustained-release preparation disclosed in the invention can achieve long-acting release, and can release drug ingredients stably and evenly within 24h.
Description
Technical field
The present invention relates to slow releasing preparation agent, relate in particular to mannose ester slow releasing preparation and preparation method thereof, belong to mannose ester slow releasing preparation field.
Background technology
Mannose ester is the sodium sulfate salt of the polymannuronate propyl ester that sodium alginate is hydrolyzed, esterification forms, and belongs to blood fat reducing, antithrombotic marine drug, is used for the treatment of hyperlipemia.
Slow releasing preparation can be stablized blood drug level after administration, reduces the incidence rate of untoward reaction, improves the safety of medication.
Existing mannose ester slow releasing preparation can not discharge stably mannose ester in 24 hours, can not reach the effect of slow release, balanced administration, had much room for improvement.
Summary of the invention
One of object of the present invention is to provide a kind of mannose ester slow releasing preparation of safe, steady in 24 hours, balanced release of active ingredients;
Two of object of the present invention is to provide a kind of method of preparing described mannose ester slow releasing preparation.
Above-mentioned purpose of the present invention is achieved through the following technical solutions:
A kind of mannose ester slow releasing preparation, comprising: mannose ester and pharmaceutical adjunct; Described pharmaceutical adjunct comprises: filler, sustained-release matrix substrate, surfactant, lubricant and bonding agent.
By weight, the consumption of each composition is preferably:
Preferred, the consumption of each composition is:
Described sustained-release matrix substrate is selected from one or more in polyvinylpyrrolidone, methylcellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose or polyoxyethylene.The kind of sustained-release matrix substrate and the selection of consumption are directly connected to the speed of drug release and even the stability of preparation, inventor finally determines by a large amount of tests, sustained-release matrix substrate is made up of polyvinylpyrrolidone and hydroxypropyl cellulose, especially by the sustained-release matrix substrate of the two composition of the part by weight according to the 2:1 of institute, drug release is the most steady, blood concentration fluctuation minimum can discharge stably in 24 hours, had best slow release effect.
Described surfactant is preferably sodium lauryl sulphate, Tween-80, poloxamer, Polyethylene Glycol caprylin, Polyethylene Glycol certain herbaceous plants with big flowers acid glyceride, Polyethylene Glycol glyceryl laurate ester or Polyethylene Glycol tristerin.
Described filler can be lactose, sugar, corn starch, calcium phosphate, sorbitol or glycine;
Described lubricant is magnesium stearate or Pulvis Talci; Described bonding agent is that concentration is more than 90% ethanol.
Desired another technical problem of the present invention is to provide a kind of method of preparing described mannose ester slow releasing preparation, comprises the following steps: by mannose ester, filler and slow release skeletal matrix mix homogeneously; Add bonding agent, soft material processed, dry, granulate; Add lubricant, mix homogeneously, tabletting, to obtain final product.
Mannose ester slow releasing preparation drug release of the present invention is steady, and blood concentration fluctuation is little, and release of active ingredients that can be steady, balanced in 24 hours has good slow release effect.
Detailed description of the invention
Further describe the present invention below in conjunction with specific embodiment, advantage and disadvantage of the present invention will be more clear along with description.But these embodiment are only exemplary, scope of the present invention are not formed to any restriction.It will be understood by those skilled in the art that lower without departing from the spirit and scope of the present invention and can the details of technical solution of the present invention and form be modified or be replaced, but these amendments and replacement all fall within the scope of protection of the present invention.
The preparation of embodiment 1 mannose ester slow releasing preparation
Take each component by following weight portion:
By mannose ester, filler and slow release skeletal matrix mix homogeneously; Add bonding agent, soft material processed, dry, granulate; Add again lubricant, mix homogeneously, tabletting, to obtain final product.
The preparation of embodiment 2 mannose ester slow releasing preparation
Take each component by following weight portion:
By mannose ester, filler and slow release skeletal matrix methylcellulose mix homogeneously; Add bonding agent, soft material processed, dry, granulate; Add again lubricant, mix homogeneously, tabletting, to obtain final product.
The preparation of embodiment 3 mannose ester slow releasing preparation
Take each component by following weight portion:
By mannose ester, filler and slow release skeletal matrix hydroxypropyl cellulose mix homogeneously; Add bonding agent, soft material processed, dry, granulate; Add again lubricant, mix homogeneously, tabletting, to obtain final product.
The preparation of embodiment 4 mannose ester slow releasing preparation
Take each component by following weight portion:
Sustained-release matrix substrate is made up of according to 1:1 part by weight polyvinylpyrrolidone and hydroxypropyl cellulose;
Preparation method is with embodiment 1.
The preparation of embodiment 5 mannose ester slow releasing preparation
Take each component by following weight portion:
Sustained-release matrix substrate is made up of according to 2:1 part by weight polyvinylpyrrolidone and hydroxypropyl cellulose;
Preparation method is with embodiment 1.
The preparation of embodiment 6 mannose ester slow releasing preparation
Take each component by following weight portion:
Sustained-release matrix substrate is made up of according to 3:1 part by weight polyvinylpyrrolidone and hydroxypropyl cellulose;
Preparation method is with embodiment 1.
The preparation of embodiment 7 mannose ester slow releasing preparation
Take each component by following weight portion:
Sustained-release matrix substrate is made up of according to 4:1 part by weight polyvinylpyrrolidone and hydroxypropyl cellulose;
Preparation method is with embodiment 1.
The preparation of embodiment 8 mannose ester slow releasing preparation
Take each component by following weight portion:
Sustained-release matrix substrate is made up of according to 5:1 part by weight polyvinylpyrrolidone and hydroxypropyl cellulose;
Preparation method is with embodiment 1.
The preparation of embodiment 9 mannose ester slow releasing preparation
Take each component by following weight portion:
Sustained-release matrix substrate is made up of according to 1:2 part by weight polyvinylpyrrolidone and hydroxypropyl cellulose;
Preparation method is with embodiment 1.
The preparation of embodiment 10 mannose ester slow releasing preparation
Take each component by following weight portion:
Sustained-release matrix substrate is made up of according to 1:3 part by weight polyvinylpyrrolidone and hydroxypropyl cellulose;
Preparation method is with embodiment 1.
The preparation of embodiment 11 mannose ester slow releasing preparation
Take each component by following weight portion:
Sustained-release matrix substrate is made up of according to 1:4 part by weight polyvinylpyrrolidone and hydroxypropyl cellulose;
Preparation method is with embodiment 1.
The preparation of embodiment 12 mannose ester slow releasing preparation
Take each component by following weight portion:
Sustained-release matrix substrate is made up of according to 1:5 part by weight polyvinylpyrrolidone and hydroxypropyl cellulose;
Preparation method is with embodiment 1
The preparation of embodiment 13 mannose ester slow releasing preparation
Take each component by following weight portion:
Sustained-release matrix substrate is made up of according to 2:1 part by weight polyvinylpyrrolidone and methylcellulose;
Preparation method is with embodiment 1.
The preparation of embodiment 14 mannose ester slow releasing preparation
Take each component by following weight portion:
Sustained-release matrix substrate is made up of according to 2:1 part by weight hydroxypropyl methylcellulose and methylcellulose;
Preparation method is with embodiment 1.
The drug release determination test of test example 1 mannose ester slow releasing preparation
According to drug release determination method (with reference to 2000 editions two annex XD first methods of Chinese Pharmacopoeia), adopt dissolution method (2000 editions two annex XC first methods of Chinese Pharmacopoeia), measure the dissolution of the prepared slow releasing preparation mannose ester in 24 hours of embodiment 1-14.Result of the test is in table 1.
Table 1 Dissolution Rate Testing result
| ? | 1 hour | 4 hours | 8 hours | 12 hours | 16 hours | 20 hours | 24 hours |
| Embodiment 1 | 35% | 58% | 84% | 100.1% | ? | ? | ? |
| Embodiment 2 | 32% | 54% | 81% | 101.2% | ? | ? | ? |
| Embodiment 3 | 27% | 46% | 68% | 89% | 100% | ? | ? |
| Embodiment 4 | 22% | 45% | 66% | 83% | 94% | 100.2% | ? |
| Embodiment 5 | 12% | 24% | 36% | 55% | 72% | 85% | 100.2% |
| Embodiment 6 | 24% | 35% | 61% | 82% | 93% | 100.2% | ? |
| Embodiment 7 | 25% | 41% | 63% | 85% | 94% | 100% | ? |
| Embodiment 8 | 26% | 45% | 65% | 86% | 95% | 100.2% | ? |
| Embodiment 9 | 31% | 52% | 76% | 93% | 100.3% | ? | ? |
| Embodiment 10 | 29% | 50% | 71% | 87% | 96% | 100.3% | ? |
| Embodiment 11 | 32% | 49% | 78% | 91% | 100.5% | ? | ? |
| Embodiment 12 | 31% | 43% | 69% | 84% | 94% | 100.2 | ? |
| Embodiment 13 | 34% | 56% | 81% | 100% | ? | ? | ? |
| Embodiment 14 | 37% | 59% | 86% | 100.2% | ? | ? | ? |
From result of the test, mannose ester slow releasing preparation of the present invention can discharge mannose ester stably, and wherein, the release mannose ester that the prepared slow releasing preparation of embodiment 5 can be steady, balanced in 24 hours, has best slow release effect.
Claims (1)
1. a mannose ester slow releasing preparation, is characterized in that, is made up of the component of following weight portion:
Sustained-release matrix substrate is made up of according to 2:1 part by weight polyvinylpyrrolidone and hydroxypropyl cellulose.
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| CN103127020B (en) * | 2013-02-19 | 2014-07-23 | 青岛正大海尔制药有限公司 | Alfacalcidol sustained-release preparation and preparation method thereof |
| CN105395499B (en) * | 2015-12-07 | 2019-02-15 | 正大制药（青岛）有限公司 | A kind of stable mannose ester piece and preparation method thereof |
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| JP2511577B2 (en) * | 1991-02-05 | 1996-06-26 | 株式会社紀文食品 | Sustained-release preparation consisting of propylene glycol alginate |
| US5646130A (en) * | 1995-06-30 | 1997-07-08 | Ocean University Of Oingdao | Low molecular weight sulfated polysaccharides and uses thereof |
| EP1195160B1 (en) * | 2000-10-05 | 2009-09-16 | USV Ltd. | Sustained release trimetazidine pharmaceutical compositions and a method of their preparation |
| CN1957928A (en) * | 2005-09-26 | 2007-05-09 | 北京吉厚成科技有限公司 | Controlled release preparation of clinical treating medication, and fabricating method |
| CN101006989A (en) * | 2005-09-26 | 2007-08-01 | 刘凤鸣 | Slow release preparation of alginic sodium diester |
| US9238008B2 (en) * | 2011-03-04 | 2016-01-19 | Institut National de la Sante et da la Recherche Medicale (INSERM) | Particles containing a growth factor, and uses thereof |
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Address after: 266103 Qingdao economic and Technological Development Zone, unity Road, No. 3601, Shandong Applicant after: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. Address before: 266103 Haier Road, Shandong, Qingdao, No. 1 Applicant before: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. |
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Address after: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee after: Zhengda Pharmaceutical (Qingdao) Co., Ltd. Address before: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee before: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. |
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Address after: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee after: Zhengda Pharmaceutical (Qingdao) Co., Ltd. Address before: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee before: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. |
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