CN109820836A - Levorotation carnitine sustained-release microcapsule powder and preparation method thereof - Google Patents
Levorotation carnitine sustained-release microcapsule powder and preparation method thereof Download PDFInfo
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Abstract
Levorotation carnitine sustained-release microcapsule powder and preparation method thereof, described method includes following steps: wall material 1. being put into dissolution in ethyl alcohol and is configured to the uniform coating solution I that solid content is 13%；The wall material is to be sustained retarding agent and plasticizer according to the mixture of mass ratio 10~15:0.5~0.75；2. being coated in a fluidized bed with coating solution I to core material, the core material is L-carnitine；Temperature of charge is 43~44 DEG C in fluidized bed, 15~35m of air quantity3/ h, heat dry 15~20min, and levorotation carnitine sustained-release microcapsule powder is made.Method of the invention can be effectively coated to L-carnitine, form protective layer, and L-carnitine and external environment are completely cut off, solve the problems, such as that its is bibulous, while it being made to have certain slow release effect, form microcapsule granule product.85% or more the effective content of L-carnitine in product, technical process is simple, is not related to chemical reaction and environmental pollution.
Description
Technical field
The present invention relates to the L-carnitine products and preparation method thereof with controlled-release effect.
Background technique
L-carnitine (L-carnitine) is carnitine system quaternary amine (3- hydroxyl-a- trimethyl-aminobutyric acid), and chemistry is entitled
(3R)-(-) -3- hydroxyl -4- trimethylammonium butyric acid (beta-hydroxy-gamma-aminobutyric acid), also known as l-carnitine, levocarnitine, creotoxin or
DL-carnitine chloride.When pH is neutral, L-carnitine exists in the form of lactone, white crystalline powder, easy to absorb moisture, slightly
Special fishy smell is amphoteric compound, and stability is preferable, can be placed 1 year or more in the solution of pH3~6, is resistant to 200 DEG C or more
High temperature.
L-carnitine is widely present in animals and plants, in microbial body, be microorganism, animal and plant basis it
One.Studies have shown that L-carnitine is a kind of nutrient of naturally occurring biostearin, can promote adipose conversion is energy, tool
There are many physiological functions, as adjusted acyl group ratio in mitochondria, promoting fatty acid beta oxidation, toxin expelling, fatigue-resisting function.It is flowing
Under capable low fat high-carbon diet and high pressure working environment, the L-carnitine taken in from diet daily is less than 50mg
Body is set to reach ideal health status, the daily diet of average adult should be no less than 500mg.In fact, only by human body synthesis and
It is horizontal that full diet source can't reach optimal carnitine intake at present.
Since L-carnitine hygroscopicity is too strong, easily agglomerate modifying characteristics, L-carnitine sterling is seldom directly sold in the market.
Presently commercially available L-carnitine product is mainly L-carnitine salt or derivatives thereof, such as L-carnitine-L-tartrate, L-carnitine
Fumarate, L-carnitine hydrochloride, acetyl-L-carnitine etc..Either with dairy products, beer, beverage, effervescent tablet, capsule and coffee
The sale of the forms such as coffee.Nowadays L-carnitine has been applied to the fields such as medicine, health care and food, and by Switzerland, France, the U.S. and
The World Health Organization is defined as legal multipurpose nutritive agent.Therefore new L-carnitine technology and product are urgently developed, to expire
The ever-increasing market demand of foot.
Summary of the invention
The object of the present invention is to provide a kind of dietary supplements, said preparation can should slowly, constantly discharge a free left side
Carnitine is revolved for absorption of human body.For this purpose, present invention firstly provides a kind of preparation method of levorotation carnitine sustained-release microcapsule powder, including it is as follows
Step:
1. wall material, which is put into dissolution in ethyl alcohol, is configured to the uniform coating solution I that solid content is 13%；The wall material is slow
Retarding agent and plasticizer are released according to the mixture of mass ratio 10~15:0.5~0.75；
2. being coated in a fluidized bed with coating solution I to core material, the core material is L-carnitine；Material in fluidized bed
Temperature is 43~44 DEG C, 15~35m of air quantity3/ h, heat dry 15~20min, and levorotation carnitine sustained-release microcapsule powder is made.
The preparation-obtained levorotation carnitine sustained-release microcapsule powder exterior appearance of the above method is white powder particle, is had excellent
Good moisture resistance, for average particle size distribution in 250nm~75nm, product mobility is outstanding；L-carnitine content should in product
85%~90%；Oral test result show, can slowly, the free L-carnitine of sustained release is for absorption of human body, In Vitro Dissolution
Degree detects the 1/2h 40% in dissolution medium hereinafter, 2h 70% is hereinafter, 80% or more 4h, is suitble to capsule, tablet or solid
Any form such as beverage is taken, and can be applied to granule, pulvis, pill, tablet, pastille or capsule.And preparation process mistake
Journey is simply mild, is not related to chemical reaction and environmental pollution, the structure and physiological activity of lossless L-carnitine, whole process green
Environmental protection is consumed energy low, and industrialization production is conducive to.
Based on this, the purpose of another aspect of the present invention, which is lain also in, provides levorotation carnitine sustained-release prepared by the above method
Microcapsule powder.
Specific embodiment
The present invention provides a kind of levorotation carnitine sustained-release microcapsule powder and preparation method thereof, and the preparation method includes following step
It is rapid:
1. wall material, which is put into dissolution in ethyl alcohol, is configured to the uniform coating solution I that solid content is 13%；The wall material is slow
Retarding agent and plasticizer are released according to the mixture of mass ratio 10~15:0.5~0.75；
2. being coated in a fluidized bed with coating solution I to core material, the core material is L-carnitine；Material in fluidized bed
Temperature is 43~44 DEG C, 15~35m of air quantity3/ h, heat dry 15~20min, and levorotation carnitine sustained-release microcapsule powder is made.
In the description of the above method, the mass ratio of the wall material and core material is preferably 10~15:85~90.
In specific embodiment, the step 1. in sustained release retarding agent be selected from hydroxypropyl first class cellulose, stearic acid, bar
Western palm wax, acrylic resin, ethyl cellulose, one of methylcellulose, permanent acrylic's resin or any more
The mixture of kind.More preferable ethyl cellulose.Most preferred viscosity is the ethyl cellulose of 4~20mpa.s.Most preferred viscosity is
The ethyl cellulose of 4mpa.s.In this embodiment, it makes full use of the film-forming type of ethyl cellulose good and has no toxic side effect
Feature, adjustment obtain ratio and viscosity appropriate and form it into the left side for having certain dissolution rate using fluidized bed coating technique
Revolve carnitine particle.Grain structure is that ethyl cellulose is uniformly wrapped in L-carnitine raw material surface, when particle disperses in water,
It is gradually penetrated into inside particle since the embedding of ethyl cellulose can control moisture, acquisition slowly, constantly discharges free
The product characteristic of L-carnitine.4h or more slow release is able to extend soak time and improves bioavilability.
In specific embodiment, the step 1. in plasticizer be selected from medium chain triglyceride (MCT), two fourth of decanedioic acid
One of ester, oleic acid, glycerol, polyethylene glycol, glyceryl triacetate, castor oil or any a variety of mixture.It is preferred that middle chain
Triglycerides (MCT).
In specific embodiment, the mass ratio of the core material, sustained release retarding agent and plasticizer is 85~90:15:0.75.
Below with reference to embodiment, the content of the present invention will be further explained, but that does not answer is interpreted as to arbitrary shape of the present invention
The restriction of formula.Unless otherwise specified, no specified otherwise, heretofore described medium chain triglyceride are purchased from IOI model 60/
40。
Process in leaching of the present invention using dissolution in vitro experiment simulation L-carnitine in enteron aisle, experimental method are as follows:
It is according to progress drug release determination referring to 711 > DISSOLUTION of USP < and " Chinese pharmacy experiment ", dissolution medium is water, is turned
Speed is 75r/min, and temperature is 37 DEG C ± 0.5 DEG C, in dissolution 1/4h, 1/2h, 3/4h, 1h, 2h, 3h, 4h sampling filtering, using height
Chloric acid titration, and the isometric dissolution medium of equality of temperature is supplemented rapidly.
The content and dissolution determination method of L-carnitine are referring to GB/T " GB25550-2010 ".
" sustained release " of the present invention, which can be considered, is essentially identical to following term: continuous release, delays to release control release
It puts, sustained release, gradually release, long-term release, program release, extended release, proportional release, delay discharge, are slow, slow
Release, interval release time controlled released, retarding action, extension effect, timesharing effect, long-acting, prolongation of effect, slow effect, continuous action,
Continuous action etc..
Embodiment 1: levorotation carnitine sustained-release microcapsule powder A and its evaluation
1, levorotation carnitine sustained-release microcapsule powder A is prepared
1) ethyl cellulose (viscosity 20mpa.s) 150g, medium chain triglyceride 0.75g are put into 1100mL ethyl alcohol and is dissolved
It is configured to uniform coating solution Ia；
2) L-carnitine raw material 1000g is weighed to pour into fluidized bed；
3) L-carnitine raw material being coated using coating solution Ia, temperature of charge is controlled at 43~44 DEG C in fluidized bed,
Air quantity 35m3/ h heat dries 20min or so and obtains levorotation carnitine sustained-release microcapsule powder A.
2, levorotation carnitine sustained-release microcapsule powder A prepared by above-mentioned 1 is evaluated
Using perchloric acid titration, the content for measuring L-carnitine in levorotation carnitine sustained-release microcapsule powder A is 85.0%；
Dissolution rate detection dissolved out 4 hours in 0.1M hydrochloric acid 900mL, in 1/4,1/2,3/4,1,2,3,4 hour acquisition sample
Product detect release result (as shown in table 1) using perchloric acid titration.
Embodiment 2: levorotation carnitine sustained-release microcapsule powder B and its evaluation
1, levorotation carnitine sustained-release microcapsule powder B is prepared
1) ethyl cellulose (viscosity 20mpa.s) 108.8g, medium chain triglyceride 0.75g are put into molten in 1100mL ethyl alcohol
Solution is configured to uniform coating solution Ib；
2) L-carnitine raw material 1000g is weighed to pour into fluidized bed
3) L-carnitine raw material is coated using coating solution Ib, temperature of charge control is at 40~41 DEG C, air quantity 35m3/
H heat dries 20min or so and obtains levorotation carnitine sustained-release microcapsule powder B.
2, levorotation carnitine sustained-release microcapsule powder B prepared by above-mentioned 1 is evaluated
Using perchloric acid titration, the content for measuring L-carnitine in levorotation carnitine sustained-release microcapsule powder B is 85.1%；
Dissolution rate detection dissolved out 4 hours in 0.1M hydrochloric acid 900mL, in 1/4,1/2,3/4,1,2,3,4 hour acquisition sample
Product detect release result (as shown in table 1) using perchloric acid titration.
Embodiment 3: levorotation carnitine sustained-release microcapsule powder C and its evaluation
1, levorotation carnitine sustained-release microcapsule powder C is prepared
1) ethyl cellulose (viscosity 20mpa.s) 108.8g, medium chain triglyceride 0.75g are put into molten in 1100mL ethyl alcohol
Solution is configured to uniform coating solution Ic；
2) L-carnitine raw material 1000g is weighed to pour into fluidized bed
3) L-carnitine raw material is coated using coating solution Ic, temperature of charge control at 45~46 DEG C, air quantity 15~
35m3/ h heat dries 15~20min or so and obtains levorotation carnitine sustained-release microcapsule powder C.
2, levorotation carnitine sustained-release microcapsule powder C prepared by above-mentioned 1 is evaluated
Using perchloric acid titration, the content for measuring L-carnitine in levorotation carnitine sustained-release microcapsule powder C is 85.0%；
Dissolution rate detection dissolved out 4 hours in 0.1M hydrochloric acid 900mL, in 1/4,1/2,3/4,1,2,3,4 hour acquisition sample
Product detect release result (as shown in table 1) using perchloric acid titration.
Embodiment 4: levorotation carnitine sustained-release microcapsule powder D and its evaluation
1, levorotation carnitine sustained-release microcapsule powder D is prepared
1) ethyl cellulose (viscosity 4mpa.s) 150g, medium chain triglyceride 0.75g are put into 1100mL ethyl alcohol and is dissolved
It is configured to uniform coating solution Id；
2) L-carnitine raw material 1000g is weighed to pour into fluidized bed
3) L-carnitine raw material being coated using coating solution Id, temperature of charge is controlled at 43~44 DEG C in fluidized bed,
Air quantity 35m3/ h heat dries 20min or so and obtains levorotation carnitine sustained-release microcapsule powder D.
2, levorotation carnitine sustained-release microcapsule powder D prepared by above-mentioned 1 is evaluated
Using perchloric acid titration, the content for measuring L-carnitine in levorotation carnitine sustained-release microcapsule powder D is 85.0%；
Dissolution rate detection dissolved out 4 hours in 0.1M hydrochloric acid 900mL, in 1/4,1/2,3/4,1,2,3,4 hour acquisition sample
Product detect release result (as shown in table 1) using perchloric acid titration.
Embodiment 5: levorotation carnitine sustained-release microcapsule powder E and its evaluation
1, levorotation carnitine sustained-release microcapsule powder E is prepared
1) ethyl cellulose (viscosity 4mpa.s) 150g, medium chain triglyceride 0.75g are put into 1100mL ethyl alcohol and is dissolved
It is configured to uniform coating solution Ie；
2) L-carnitine raw material 1000g is weighed to pour into fluidized bed
3) L-carnitine raw material being coated using coating solution Ie, temperature of charge is controlled at 41~42 DEG C in fluidized bed,
Air quantity 35m3/ h heat dries 20min or so and obtains levorotation carnitine sustained-release microcapsule powder E.
2, levorotation carnitine sustained-release microcapsule powder E prepared by above-mentioned 1 is evaluated
Using perchloric acid titration, the content for measuring L-carnitine in levorotation carnitine sustained-release microcapsule powder B is 85.0%；
Dissolution rate detection dissolved out 4 hours in 0.1M hydrochloric acid 900mL, in 1/4,1/2,3/4,1,2,3,4 hour acquisition sample
Product detect release result (as shown in table 1) using perchloric acid titration.
Embodiment 6: levorotation carnitine sustained-release microcapsule powder F and its evaluation
1, levorotation carnitine sustained-release microcapsule powder F is prepared
1) ethyl cellulose (viscosity 4mpa.s) 150g, medium chain triglyceride 0.75g are put into 1100mL ethyl alcohol and is dissolved
It is configured to uniform coating solution If；
2) L-carnitine raw material 1000g is weighed to pour into fluidized bed
3) L-carnitine raw material being coated using coating solution If, temperature of charge is controlled at 45~46 DEG C in fluidized bed,
Air quantity 35m3/ h heat dries 20min or so and obtains levorotation carnitine sustained-release microcapsule powder F.
2, levorotation carnitine sustained-release microcapsule powder F prepared by above-mentioned 1 is evaluated
Using perchloric acid titration, the content for measuring L-carnitine in levorotation carnitine sustained-release microcapsule powder F is 85.7%；
Dissolution rate detection dissolved out 4 hours in 0.1M hydrochloric acid 900mL, in 1/4,1/2,3/4,1,2,3,4 hour acquisition sample
Product detect release result (as shown in table 1) using perchloric acid titration.
Embodiment 7: levorotation carnitine sustained-release microcapsule powder G and its evaluation
1, levorotation carnitine sustained-release microcapsule powder G is prepared
1) ethyl cellulose (viscosity 7mpa.s) 150g, medium chain triglyceride 0.75g are put into 1100mL ethyl alcohol and is dissolved
It is configured to uniform coating solution Ig；
2) L-carnitine raw material 1000g is weighed to pour into fluidized bed
3) L-carnitine raw material being coated using coating solution Ig, temperature of charge is controlled at 43~44 DEG C in fluidized bed,
Air quantity 35m3/ h heat dries 20min or so and obtains levorotation carnitine sustained-release microcapsule powder G.
2, levorotation carnitine sustained-release micro-capsule G prepared by above-mentioned 1 is evaluated
Using perchloric acid titration, the content for measuring L-carnitine in levorotation carnitine sustained-release microcapsule powder G is 85.4%；
Dissolution rate detection dissolved out 4 hours in 0.1M hydrochloric acid 900mL, in 1/4,1/2,3/4,1,2,3,4 hour acquisition sample
Product detect release result (as shown in table 1) using perchloric acid titration.
Embodiment 8: levorotation carnitine sustained-release microcapsule powder H and its evaluation
1, levorotation carnitine sustained-release microcapsule powder H is prepared
1) Aquacoat 600g (solid content 25%) is weighed, uniform coating solution Ih is obtained；
2) L-carnitine raw material 1000g is weighed to pour into fluidized bed
3) L-carnitine raw material being coated using coating solution Ih, temperature of charge is controlled at 43~44 DEG C in fluidized bed,
Air quantity 35m3/ h heat dries 20min or so and obtains levorotation carnitine sustained-release microcapsule powder H.
2, levorotation carnitine sustained-release microcapsule powder H prepared by above-mentioned 1 is evaluated
Using perchloric acid titration, the content for measuring L-carnitine in levorotation carnitine sustained-release microcapsule powder H is 85.0%；
Dissolution rate detection dissolved out 4 hours in 0.1M hydrochloric acid 900mL, in 1/4,1/2,3/4,1,2,3,4 hour acquisition sample
Product detect release result (as shown in table 1) using perchloric acid titration.
Table 1
As it can be seen from table 1 showing that levorotation carnitine sustained-release microcapsule powder A~H shows 4h's or more compared to raw material data
The feature of sustained release.But comparison example A, example B and example C are determined when temperature of charge is 43~44 DEG C, are that product is optimal
Technique.Comparison example A, example D, example G and example H；Example B and example E；Example C and example F determines that ethyl cellulose is (viscous
Spend 4mpa.s) it is optimization formula.
Claims (9)
1. the preparation method of levorotation carnitine sustained-release microcapsule powder, includes the following steps:
1. wall material, which is put into dissolution in ethyl alcohol, is configured to the uniform coating solution I that solid content is 13%；The wall material is sustained release resistance
Stagnant dose with plasticizer according to the mixture of mass ratio 10~15:0.5~0.75；
2. being coated in a fluidized bed with coating solution I to core material, the core material is L-carnitine；Temperature of charge in fluidized bed
It is 43~44 DEG C, 15~35m of air quantity3/ h, heat dry 15~20min, and levorotation carnitine sustained-release microcapsule powder is made.
2. preparation method according to claim 1, which is characterized in that the mass ratio of the wall material and core material be 10~
15:85~90.
3. preparation method according to claim 1, which is characterized in that step 1. described in sustained release retarding agent be selected from hydroxypropyl
Base first class cellulose, stearic acid, Brazil wax, acrylic resin, ethyl cellulose, methylcellulose, permanent acrylic
One of resin or any a variety of mixture.
4. preparation method according to claim 3, it is characterised in that the sustained release retarding agent is ethyl cellulose.
5. the preparation method according to claim 4, which is characterized in that the sustained release retarding agent be viscosity be 4~
The ethyl cellulose of 20mpa.s.
6. preparation method according to claim 1, which is characterized in that step 1. described in plasticizer be selected from medium chain triglyceride
One of three esters (MCT), dibutyl sebacate, oleic acid, glycerol, polyethylene glycol, glyceryl triacetate, castor oil are any more
The mixture of kind.
7. preparation method according to claim 6, which is characterized in that the plasticizer is medium chain triglyceride.
8. preparation method according to claim 1, which is characterized in that the core material and sustained release retarding agent and plasticizer
Mass ratio is 85~90:15:0.75.
9. a kind of levorotation carnitine sustained-release microcapsule powder, which is characterized in that be made by method described in claim 1.
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Application publication date: 20190531 |