CN104546730A - Chitosamine hydrochloride pellet preparation and preparation method thereof - Google Patents
Chitosamine hydrochloride pellet preparation and preparation method thereof Download PDFInfo
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- CN104546730A CN104546730A CN201310464855.5A CN201310464855A CN104546730A CN 104546730 A CN104546730 A CN 104546730A CN 201310464855 A CN201310464855 A CN 201310464855A CN 104546730 A CN104546730 A CN 104546730A
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- glucosamine
- glucosamine hydrochloride
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Abstract
The invention relates to a chitosamine hydrochloride pellet preparation and its preparation method. By using glucosamine extracted from marine organism as an active ingredient, the chitosamine hydrochloride pellet preparation comprises glucosamine pellets and a coating layer. The glucosamine pellets contain the following materials, by weight, 70-90% of chitosamine hydrochloride with the particle size being 30-100 microns, 10-20% of blank drug core pellets with the particle size being 0.2-1 mm, 2-10% of a binder and 0.1-1% of a flow aid. According to the chitosamine hydrochloride pellet preparation, as the whole drug release body is composed of multiple drug release units, abnormal drug release behaviors of an individual unit will not influence the whole situation. Thus, an ideal overall drug release rate can be obtained, and an expected blood concentration can be achieved. Therefore, an ideal curative effect is achieved, and the irritant effect on the gastrointestinal tract can be reduced.
Description
Technical field
The present invention relates to pharmaceutical preparation, particularly relate to a kind of utilization from ocean, in shrimp and crab shells, extract glucosamine hydrochloride pellet preparations being used for the treatment of osteoarthritis prepared by the glucosamine that obtains and preparation method thereof.
Background technology
Glucosamine hydrochloride is a kind of marine biological preparation, and white crystal, slightly sweet taste are soluble in water, is the Main Ingredients and Appearance of chondroitin sulfate.The synthesis of human body mucopolysaccharide can be promoted, improve the viscosity of knuckle synovia, the metabolism of articular cartilage can be improved, be conducive to the reparation of articular cartilage.There is obvious anti-inflammatory analgesic action.This product is by stimulating the picked-up that the biochemistry of mucopolysaccharide synthesizes and recruitment skeleton is calcareous, improve metabolic function and the nutrition of bone and cartilaginous tissue, also can improve and strengthen the viscosity of synovial fluid, increase synovial fluid synthesis, provide joint lubrication function, the pathological process of this product osteoarthritis capable of blocking, disease preventing and treating is in progress, improve joint movement function, alleviate arthralgia, suppress and joint degeneration formation of disappearing.This product is mainly used in the osteoarthritis for the treatment of and preventing the various joint of whole body, comprise knee joint, shoulder joint, hip joint, wrist joint, neck and spinal joint and ankle joint etc., can alleviate and eliminate the symptom such as pain, swelling of osteoarthritis, improve joint movement function.
Before more than 30 years, abroad studies personnel just find: person in middle and old age's Human Osteoarthritis supplemented with exogenous glucosamine can alleviate arthralgia very soon and improve ability to act.This new discovery finally causes the birth of a class new type bone joint care product, and it is exactly hydrolysis prods---the glucosamine from ocean crustacean extract " chitin ".
On international market, glucosamine product has more than 200 to plant, and North America is the fastest glucosamine market of global growth rate, and the annual compound growth rate of 2000 ~ 2013 years is 17.8%, by 2013, the share that it accounts for global glucosamine market will reach 33%, following closely be European market, annual compound growth rate is 16.1%, the China in Asia and South America area, India, Indonesia, the emerging nations such as Brazil will become the new growing point in Future Consumption market.Mintel company of market survey mechanism points out: the product quantity containing glucosamine (glucosamine) raw material released by all parts of the world businessman is the situation of steady growth.The maximum country of consumption of current glucosamine is the U.S., and on its market, aminoglucose sugar products annual rate of growth is up to 36%.But along with the raising of Chinese income level and the raising of health care consciousness, glucosamine increases year by year fast in the consumption of China.Current China more than 60 years old old man has 1.3 hundred million, wherein at least 40% suffers from osteopathia in various degree, glucosamine has good development prospect as a kind of at home undoubtedly at developed country's listing bone health promoting product for many years, expection year sells peak value and can reach 5,000,000,000 ~ 6,000,000,000 yuans.Therefore greatly develop glucosamine industry and there is boundless market prospect.
But little at the glucosamine related preparations of China's listing, mainly concentrate on powder filled-type capsule and tablet; The market share also major part is occupied by external product.In addition there are 2 problems in the application of this product:
(1) this product itself belongs to BSC and to classify 1 class medicine (high-dissolvability, high osmosis).But due to first pass effect, the bioavailability after this product is oral is less than 30%.The principal indication of this product is the diseases such as various arthritis, rickets, and it is middle-aged and elderly people mainly for crowd.This kind of people is due to the decline of physical function, and gastrointestinal absorption miopragia, the bioavailability after therefore oral is lower, cannot reach due therapeutic effect after even taking.
(2) this product easily causes gastrointestinal upset, should when meal or one after each meal (particularly having the patient of gastric ulcer).This limits its application to a certain extent.Particularly this product belongs to the ingredient of slow onset, and (according to the difference of indication, the time is not from 2 to 6 months etc. to need long-term taking; If as prophylactic, more need long-term taking), it is more seriously aobvious that this just makes glucosamine easily cause the side effect of gastrointestinal upset.
Summary of the invention
The object of the invention is to solve Problems existing in background technology, the glucosamine pellet preparations that a kind of good absorbing, biological utilisation are high, the side effect of gastrointestinal upset is little is provided.
Another object of the present invention is to the preparation method that a kind of glucosamine pellet preparations is provided.
In order to realize foregoing invention object, solve Problems existing in background technology, the present invention adopts following technical scheme:
glucosamine hydrochloride pellet preparations, comprise glucosamine element ball and coatings, described glucosamine element ball comprises the material of following percentage by weight: the glucosamine hydrochloride of 70 ~ 90%, particle diameter is 30 ~ 100 μm, the blank medicine ball core of 10 ~ 20%, particle diameter is 0.2 ~ 1mm, the binding agent of 2 ~ 10%, the fluidizer of 0.1 ~ 1%.
Described blank medicine ball core is one or more in starch ball core, microcrystalline Cellulose ball core, sucrose ball core, silicon dioxide ball core.
Described binding agent is one or more in hypromellose, starch, polyvidone, carboxymethyl starch sodium, water, 95% ethanol.
Described fluidizer is one or more in micropowder silica gel, Pulvis Talci, simethicone.
The coating material of described coatings is one or more in hypromellose, hydroxyethyl-cellulose, hydroxypropyl cellulose, ethyl cellulose, polyacrylic resin.
The invention also discloses the preparation method of glucosamine hydrochloride pellet preparations, comprise the steps:
(1) pretreatment: by glucosamine hydrochloride pulverize, sieve, then with fluidizer mix homogeneously;
(2) binding agent is configured;
(3) blank medicine ball core is placed in centrifugal granulator, regulating parameter, adopt above-mentioned binding agent to add medicine to, design parameter is as follows: main frame: 180-250rpm; Whitewashing: 5-25rpm; For powder: 5-25rpm; Air quantity: little of large; Hot blast temperature: 35-45 DEG C; Element ball temperature: 25-30 DEG C; Atomizing pressure: 0.04-0.10mPa;
(4), after having added medicine to, take out and dry to obtain plain ball;
(5) coating solution and binding agent is configured;
(6) glucosamine hydrochloride element ball is placed in centrifugal granulator, regulating parameter, adopt above-mentioned coating solution coating, design parameter is as follows: main frame: 180-250rpm; Whitewashing: 4-10rpm; Air quantity: little of large; Hot blast temperature: 35-45 DEG C; Element ball temperature: 25-35 DEG C; Atomizing pressure: 0.04-0.10mPa;
(7), after coating completes, take out and dry and obtain glucosamine hydrochloride micropill.
The glucosamine hydrochloride micropill that the present invention obtains, tool has the following advantages compared with other dosage forms:
(1) micropill can be distributed in rapidly whole gastrointestinal tract, can not locally build up, and thus gastrointestinal zest is little, and absorption is steady, bioavailability is high;
(2) because release entirety is made up of multiple drug delivery unit, the abnormal drug release behavior of Individual cells does not affect the overall situation, can obtain desirable overall rate of releasing drug, reach the blood drug level of expection, thus obtain desirable curative effect;
(3) interindividual variation of the micropill body absorption of multiple-unit release is little, and drug release kinetics is measurable, absorption dynamics favorable reproducibility;
(4) because specific surface area is much smaller than powder, the performances such as protection against the tide are more excellent; When adopting film coating, spent material is less simultaneously.
Detailed description of the invention
Below by specific embodiment, the present invention is described further
Embodiment 1: prepare glucosamine hydrochloride micropill specific as follows.
The preparation of glucosamine hydrochloride element ball:
Glucosamine hydrochloride (particle diameter 50 μm) 240g
Micropowder silica gel 2.4g
Microcrystalline Cellulose ball core (0.45 ~ 0.6mm) 60g
PVP K30 (PVP K30) 12g
95% ethanol 252.3g
Purified water 135.8g
Make 314.4g
Preparation process
1, pretreatment: glucosamine hydrochloride is crushed to appropriate particle size, then mixes with micropowder silica gel;
2, binding agent is prepared: take PVP K30, be dissolved in purified water, add 95% ethanol, stir;
3, microcrystalline Cellulose ball core is placed in centrifugal granulator, regulating parameter, adopts above-mentioned binding agent to add medicine to.Design parameter is as follows:
Main frame: 200rpm;
Whitewashing: 20rpm;
For powder: 20rpm;
Air quantity: little of large;
Hot blast temperature: 40 DEG C;
Element ball temperature: 25-30 DEG C;
Atomizing pressure: 0.08mPaa;
4, after having added medicine to, plain ball is taken out, be dried to moisture lower than 3%, obtain glucosamine hydrochloride element ball.
Element ball coating:
Glucosamine hydrochloride element ball 314.4gg
Ferrum oxide (Huang) 0.3144g
Pulvis Talci 2.1g
Hypromellose (HPMC 5CP) 6.288g
95% ethanol 152.5g
Purified water 50.8g
Make 1000
Preparation process
1. prepare coating solution: take;
2. preparation binding agent: take HPMC 5CP, be dissolved in purified water, adds 95% ethanol, stirs, and adds Pulvis Talci and ferrum oxide (Huang), is stirred to and is uniformly dispersed;
3. glucosamine hydrochloride element ball is placed in centrifugal granulator, regulating parameter, adopts above-mentioned coating solution coating.Design parameter is as follows:
Main frame: 200rpm;
Whitewashing: 8rpm;
Air quantity: little of large;
Hot blast temperature: 40 DEG C;
Element ball temperature: 30 DEG C;
Atomizing pressure: 0.08mPa;
4., after coating completes, take out, be dried to moisture lower than 3%, take out and get final product;
5. namely the glucosamine hydrochloride micropill filled capsules obtained is obtained glucosamine hydrochloride pellet capsule.
Embodiment 2: prepare glucosamine hydrochloride micropill specific as follows.
The preparation of glucosamine hydrochloride element ball:
Glucosamine hydrochloride 240g
Pulvis Talci 1.2g
Simethicone 1.2g
Starch ball core (0.45 ~ 0.6mm) 60g
HPMC（3CP） 12g
95% ethanol 204g
Purified water 109.6g
Make 314.4g
Preparation process
1. the upper drug solns of preparation: take HPMC(3CP), be dissolved in purified water, add glucosamine hydrochloride, stirring and dissolving; Add 95% ethanol, stir; Add Pulvis Talci and simethicone, stir;
2. starch ball core is placed in fluid bed, regulating parameter, adopt above-mentioned binding agent to add medicine to, design parameter is as follows:
Blower fan: 20rpm;
Feed flow: 10rpm;
Inlet temperature: 40 DEG C;
Temperature of charge: 30 DEG C;
Leaving air temp: 35 DEG C;
Atomizing pressure: 0.1mPa;
3. after having added medicine to, plain ball is taken out, be dried to moisture lower than 3%, obtain final product.
Element ball coating:
Glucosamine hydrochloride element ball 314.4gg
Titanium dioxide 0.3144g
Glyceryl monostearate 3.144g
Glyceryl Behenate 3.144g
Acrylic resin (S100) 6.288g
95% ethanol 231.1g
Purified water 77.9g
Make 1000
Preparation process
1. prepare coating solution: take glyceryl monostearate, Glyceryl Behenate, acrylic resin (S100), be dissolved in 95% ethanol; Add water and titanium dioxide, be stirred to evenly;
2. glucosamine hydrochloride element ball is placed in fluid bed, regulating parameter, adopts above-mentioned coating solution coating.Design parameter is as follows:
Blower fan: 20rpm;
Feed flow: 8rpm;
Inlet temperature: 40 DEG C;
Temperature of charge: 30 DEG C;
Leaving air temp: 33 DEG C;
Atomizing pressure: 0.1mPa;
3. after coating completes, take out, be dried to moisture lower than 3%, take out glucosamine hydrochloride micropill;
4. carry out capsule-filling according to coated pill content.
Claims (6)
1. glucosamine hydrochloride pellet preparations, comprise glucosamine element ball and coatings, it is characterized in that described glucosamine element ball comprises the material of following percentage by weight: the glucosamine hydrochloride of 70 ~ 90%, particle diameter is 30 ~ 100 μm, the blank medicine ball core of 10 ~ 20%, particle diameter is 0.2 ~ 1mm, the binding agent of 2 ~ 10%, the fluidizer of 0.1 ~ 1%.
2. glucosamine hydrochloride pellet preparations according to claim 1, is characterized in that described blank medicine ball core is one or more in starch ball core, microcrystalline Cellulose ball core, sucrose ball core, silicon dioxide ball core.
3. glucosamine hydrochloride pellet preparations according to claim 1, is characterized in that described binding agent is one or more in hypromellose, starch, polyvidone, carboxymethyl starch sodium, water, 95% ethanol.
4. glucosamine hydrochloride pellet preparations according to claim 1, is characterized in that described fluidizer is one or more in micropowder silica gel, Pulvis Talci, simethicone.
5. glucosamine hydrochloride pellet preparations according to claim 1, is characterized in that the coating material of described coatings is one or more in hypromellose, hydroxyethyl-cellulose, hydroxypropyl cellulose, ethyl cellulose, polyacrylic resin.
6., according to the preparation method of the glucosamine hydrochloride pellet preparations of claim 1 ~ 5 described in any one, it is characterized in that comprising the steps:
(1) pretreatment: by glucosamine hydrochloride pulverize, sieve, then with fluidizer mix homogeneously;
(2) binding agent is configured;
(3) blank medicine ball core is placed in centrifugal granulator, regulating parameter, adopt above-mentioned binding agent to add medicine to, design parameter is as follows: main frame: 180-250rpm; Whitewashing: 5-25rpm; For powder: 5-25rpm; Air quantity: little of large; Hot blast temperature: 35-45 DEG C; Element ball temperature: 25-30 DEG C; Atomizing pressure: 0.04-0.10mPa;
(4), after having added medicine to, take out and dry to obtain plain ball;
(5) coating solution and binding agent is configured;
(6) glucosamine hydrochloride element ball is placed in centrifugal granulator, regulating parameter, adopt above-mentioned coating solution coating, design parameter is as follows: main frame: 180-250rpm; Whitewashing: 4-10rpm; Air quantity: little of large; Hot blast temperature: 35-45 DEG C; Element ball temperature: 25-35 DEG C; Atomizing pressure: 0.04-0.10mPa;
(7), after coating completes, take out and dry and obtain glucosamine hydrochloride micropill.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310464855.5A CN104546730A (en) | 2013-10-09 | 2013-10-09 | Chitosamine hydrochloride pellet preparation and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310464855.5A CN104546730A (en) | 2013-10-09 | 2013-10-09 | Chitosamine hydrochloride pellet preparation and preparation method thereof |
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| CN104546730A true CN104546730A (en) | 2015-04-29 |
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| CN201310464855.5A Pending CN104546730A (en) | 2013-10-09 | 2013-10-09 | Chitosamine hydrochloride pellet preparation and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114146066A (en) * | 2021-12-16 | 2022-03-08 | 山东润德生物科技有限公司 | Preparation method and application of glucosamine preparation with high stability |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050181047A1 (en) * | 2004-02-18 | 2005-08-18 | Jaime Romero | Compositions and methods for timed release of water-soluble nutritional supplements |
| CN101642461A (en) * | 2008-08-07 | 2010-02-10 | 杨喜鸿 | Drug composition of iguratimod and glucosamine, preparation method and drug application thereof |
| CN101703475A (en) * | 2009-11-20 | 2010-05-12 | 天津市弗兰德医药科技发展有限公司 | Chondroitin sulfate pellet and preparation method thereof |
| CN103800290A (en) * | 2012-11-07 | 2014-05-21 | 杭州赛利药物研究所有限公司 | Glucosamine hydrochloride pellet preparation and preparation method thereof |
-
2013
- 2013-10-09 CN CN201310464855.5A patent/CN104546730A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050181047A1 (en) * | 2004-02-18 | 2005-08-18 | Jaime Romero | Compositions and methods for timed release of water-soluble nutritional supplements |
| CN101642461A (en) * | 2008-08-07 | 2010-02-10 | 杨喜鸿 | Drug composition of iguratimod and glucosamine, preparation method and drug application thereof |
| CN101703475A (en) * | 2009-11-20 | 2010-05-12 | 天津市弗兰德医药科技发展有限公司 | Chondroitin sulfate pellet and preparation method thereof |
| CN103800290A (en) * | 2012-11-07 | 2014-05-21 | 杭州赛利药物研究所有限公司 | Glucosamine hydrochloride pellet preparation and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114146066A (en) * | 2021-12-16 | 2022-03-08 | 山东润德生物科技有限公司 | Preparation method and application of glucosamine preparation with high stability |
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Application publication date: 20150429 |