CN106018207A - Method for detecting particle dissolution rate - Google Patents
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- CN106018207A CN106018207A CN201610642745.7A CN201610642745A CN106018207A CN 106018207 A CN106018207 A CN 106018207A CN 201610642745 A CN201610642745 A CN 201610642745A CN 106018207 A CN106018207 A CN 106018207A
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- granule
- dissolution rate
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume, or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
- G01N15/0205—Investigating particle size or size distribution by optical means, e.g. by light scattering, diffraction, holography or imaging
- G01N15/0211—Investigating a scatter or diffraction pattern
Abstract
The invention provides a method for detecting particle dissolution cases. The method comprises putting particles with the sizes of 0.1-1000 microns into a transparent container, adding a solvent into the container, carrying out stirring dissolution, taking a particle dispersion liquid, diluting the particle dispersion liquid through a solvent, adding the solution into a laser particle analyzer, detecting a shading ratio through a particle size distribution detection method and recording the shading ratio. The method is first disclosed, effectively detects particle dissolution cases, is accurate, convenient and simple and realizes a low cost. In actual detection, the method realizes unification of detection standards of the same type of particles obtained by different technologies, realizes quantification of a dissolution rate and degree, provides detection standards for the existing problems and effectively guarantees detection data accuracy.
Description
Technical field
The present invention relates to Chinese medicine processing technology field, particularly belong to the detection method of a kind of granule dissolution rate.
Background technology
Along with the development of medical science, quality and the requirement increasingly stringent of drug effect to medicine.According to different medication requirements, use
Medicine approach and the difference of physical and chemical properties of drugs, can be made into various pharmaceutical dosage form, to be suitable for the demand of clinic.Medicine is from medication portion
Divide the process entering blood, be referred to as absorbing.For solid preparation, the process of absorption can be summarized as two steps: (1) medicine from
Dosage form discharges, dissolves；(2) medicine is absorbed by biomembrane.Back is based on dosage form, and a rear step is with physiologic factor
It is main.For same medicine, its absorbtivity is generally in proportion to medicine amount (amount i.e. leached) of dissolution diffusion from dosage form,
So in order to preferably play medicine effect, Chinese medicine produces relevant dosage form must control to leach the time limit, detects dissolution rate.
Leach after referring to that drug particles meets water, the dissolving occurred in water and deployment conditions, this is wettability based on medicine,
Surface is i.e. readily wetted by water, and moisture is constantly entered inside granule by capillary tube and hole, and some starch in granule become with fiber etc.
Dividing moisture expantion, fractions dissolves, and under other factor effects so that grain structure is loose to be ruptured and disperses.
The dissolution rate of granule has a following influence factor: the character of medicine, the water content of granule, granular size, the character of excipient
With consumption, process, dry method and temperature etc..The purpose leached is to spread out granule as far as possible, will wherein
The composition that can dissolve is dissolved in liquid fully, rapidly, improves effective utilization of medicine.Inspection for the dissolution rate of granule
Survey, currently mainly use and granule is placed in water/solvent, the situation of residual particles after people's perusal leaches within the time of regulation,
The dissolution rate of granule is judged with this.The method uses people's perusal, it is impossible to accurate description dissolution rate, and artificial subjective because of
Element impact is big.It addition, leach detection for current, there is no quantitative detection method so that subjective factors impact is big, the most really
Qualitative height.
Chinese medicine wall cell disruption decoction pieces, also known as Chinese medicine ultra-fine powder or Chinese medicine cell grade micropowder, uses superfine communication technique to be carried out carefully by tradition decoction pieces
A kind of preparing new-type medical herbs drink tablets that born of the same parents' level smashes and pelletizes.Owing to processing without high temperature extraction, Chinese medicine wall cell disruption decoction pieces retains tradition
Whole compositions of decoction pieces；Again because of the introducing of wall breaking technology, composition dissolution rate is fast and dissolution is high, improves the profit of effective ingredient
By rate, medicament-saving resource；Can directly brew takes without decoction, can add and subtract with disease, and compatibility is flexible, and it is convenient to apply.Mesh
The front quality research for breaking cellular wall decoction pieces, the most perfect.
Laser particle analyzer is the general particle size analyzer measuring granular size according to scattering of light principle, has measuring speed model fast, dynamic
Enclose the advantages such as big, easy and simple to handle, reproducible, be the testing graininess instrument that the whole world is popular, accuracy error about 3%,
Repeatability deviation is about 3%；Measurement scope is at 0.1～600 micron.This instrument can make laser produce according to granule and scatter this thing
Reason phenomenon test dynamics distribution, owing to laser has good monochromaticity and extremely strong directivity, thus unencumbered infinitely
In space, laser will be irradiated to the place of infinity, and seldom has the phenomenon dissipated in communication process.Laser particle analyzer is surveyed
Trying certain sample when not having granule, light beam will be focused on the center of the annular photodetector of instrument, and shines through the aperture at center
It is mapped in central detector.When there being granule in sample, some is scattered by the particles annular detector by the light beam of convergence
On each probe unit and big angle detector, these luminous energy the shading ratio drawn, sample concentration is the biggest, and shading ratio is the biggest.
Summary of the invention
For the deficiencies in the prior art, the present invention provides the dissolution rate detection method of a kind of granule, the especially granule of breaking cellular wall decoction pieces
The detection method of dissolution rate, the shading ratio of the solution after using laser detecting apparatus detection to leach first, and then the feelings that reflection leaches
Condition, the method for the present invention can effectively detect dissolution rate and dissolution rate can be carried out detection by quantitative.
For solving above-mentioned technical problem, the present invention provides following technical scheme: the detection method of a kind of granule dissolution rate, specifically examines
Survey step is: 1) prepared by standard substance working solution: takes the standard substance granule that particle diameter is 0.1～1000 micron and is placed in transparent vessel,
Add and stir 1～20 minute prepared particle dispersion after 20～100 DEG C of solvents, take particle dispersion immediately to constant volume in volumetric flask,
Prepared concentration is the standard substance working solution of 2～20mg/mL；2) standard curve is drawn: by step 1) the middle standard substance work prepared
Join in laser particle analyzer injector as liquid, use particle size distribution detection method detection shading ratio, draw standard curve, obtain
Standard curve equation；3) prepared by product to be tested: takes the product to be tested granule that particle diameter is 0.1～1000 micron and is placed in transparent vessel, presses
Step 1) described in method process after prepare particle dispersion, stand 10～200 seconds, take particle dispersion in volumetric flask
After solvent dilution constant volume, by product to be tested by step 2) described method detection shading ratio, the shading of product to be tested is compared step 2)
The standard curve drawn, finds out the concentration of correspondence, thus quantitatively draws the dissolution rate of granule.
The concentration of described standard substance working solution is 2,4,6,8,10,12,14,16,18,20mg/mL；By described standard
After the detection of product working solution, draw standard curve by the relation of concentration with shading ratio, concentration calculate corresponding granule dissolution rate,
Obtain the coefficient R of standard curve2More than 0.99.
Described concentration calculates corresponding granule dissolution rate, refers to the amount becoming granule to leach concentration conversion, i.e. dissolution rate=[(screening
Light ratio × slope)-intercept]/(test sample/amount of solution × sampling amount) × 100%.Described slope is the slope of standard curve；Described
Intercept is the intercept of standard curve.
The particle diameter of described standard substance granule or product to be tested granule is 1～50 micron.It is further preferred that described standard substance granule or treat
Survey product granule is breaking cellular wall decoction pieces.
Described step 1) or step 3) in take the amount of granule be 1～5.0g.The volume of described transparent vessel is 100～250mL.
It is further preferred that described step 1) or step 3) in take the amount of granule be 2.0g or 4.0g.
Described step 1) or step 3) in solvent be organic solvent or water；Described step 1) or step 3) in the temperature of solvent
It it is 20～100 DEG C；The amount of solvent is 50～100mL.It is further preferred that described step 1) or step 3) in solvent be water；
Described temperature is 90～95 DEG C.Described organic solvent refers to alcohols, ethers, ketone, alkanes, aromatics or lipid etc..
Described step 1) or step 3) in mixing speed be per second 0.2～5 circle.It is further preferred that described step 1) or step
Rapid 3) in, mixing speed is per second 1～2 circles.
Described step 1) or step 3) in mixing time be 1～20 minute.It is further preferred that described step 1) or step 3)
Middle mixing time is 5 minutes.
Described step 3) in take particle dispersion solvent dilution constant volume and refer to take the liquid 0.2～5mL in chaotropic face 1～5cm extremely
Constant volume dilution in 10mL volumetric flask.It is further preferred that described time of repose is 30 seconds.It is further preferred that described step
3) take particle dispersion dilution in and refer to take the liquid capacity-fixed dilution of chaotropic face 2cm.
Described laser particle analyzer is not limited to American-European gram LS-609 laser particle analyzer.
The operating process of described particle size distribution detection method is: arrange the parameter of laser particle analyzer, selects disperse medium, before measurement
Ultrasonic 10～100 seconds, other parameters such as index of refraction all selected default value, read shading ratio.Further, described disperse medium choosing " water ",
Ultrasonic time is 30 seconds.The solvent according to leaching granule that selects of described disperse medium selects accordingly.
Further, granule of the present invention is Semen Coicis decoction pieces, Cortex Cinnamomi decoction pieces etc..
Normal equation is compared in concentration-shading that described standard curve equation sets up oneself uniqueness according to the dissolution rate of every kind of material.
Beneficial effects of the present invention:
The present invention provides the detection method of a kind of granule dissolution rate, and the method, for providing first, can effectively detect what granule leached
Situation, accurate, convenient, simple, low cost.During the method is actually detected, for same kind variable grain and different process system
The examination criteria of standby granule can be unified, the energetic speed leached and degree, and the deficiencies in the prior art provide inspection mark
Standard, the effective accuracy ensureing detection data, the dissolution rate of the same kind granule of contrast different process advantageously ensures that and leaches
The drug effect of granule, improve the controllability of product quality, be that in Chinese medicine development innovates greatly.
The operational approach that the present invention provides is simple, workable, and precision is high, favorable reproducibility, low cost, and being suitable for industry should
With.
Accompanying drawing explanation
The canonical plotting of Fig. 1 the preferred embodiments of the present invention 1；
The canonical plotting of Fig. 2 the preferred embodiments of the present invention 2.
Wherein, X is shading ratio, represents decimally；Y is concentration, unit mg/10ml.
Detailed description of the invention
With specific embodiment, the present invention is further illustrated below, but the present invention is not limited by following embodiment.
Brief word is explained:
ML milliliter；G gram；Mg milligram；DEG C degree Celsius.
The relation test leaching concentration and shading ratio of embodiment 1 Semen Coicis breaking cellular wall decoction pieces
1) Semen Coicis breaking cellular wall decoction pieces 2g is taken, accurately weighed, it is placed in 100mL beaker, is slowly added into precision along walls of beaker and measures
50mL water；
2) granule in beaker and solvent being carried out strong stirring makes granule disperse in 5 minutes；After shaking all, precision measures 0.5 the most respectively
mL、1.0mL、1.5mL、2.0mL、2.5mL、3.0mL、3.5mL、4.0mL、4.5mL、5.0mL
Particle dispersion is in 10mL volumetric flask；
3) take appropriate water constant volume, the particle dispersion after dilution added in the injector of American-European gram LS-609 laser particle analyzer,
Operate according to particle size distribution detection method, the parameter of laser particle analyzer is set, super before disperse medium choosing " water ", measurement
Sound 30 seconds, other parameters such as index of refraction are all selected default value, are read shading ratio, and record result such as table 1 below.
Table 1
| Dispersion liquid measure | 0.5mL | 1.0mL | 1.5mL | 2.0mL | 2.5mL |
| Add the water yield | 9.5mL | 9.0mL | 8.5mL | 8.0mL | 7.5mL |
| Concentration (mg/mL) | 2.0035 | 4.0070 | 6.0105 | 8.0140 | 10.0175 |
| Shading ratio | 2.36% | 6.84% | 10.60% | 14.24% | 16.68% |
| Dispersion liquid measure | 3.0mL | 3.5mL | 4.0mL | 4.5mL | 5.0mL |
| Add the water yield | 7.0mL | 6.5mL | 6.0mL | 5.5mL | 5.0mL |
| Concentration (mg/mL) | 12.0210 | 14.0245 | 16.0280 | 18.0315 | 20.0350 |
| Shading ratio | 19.44% | 23.09% | 25.84% | 27.92% | 30.04% |
Data in table 1 are calculated, make standard curve such as accompanying drawing 1, show that linearity of regression equation is Y=651.8X-5.219,
Coefficient R2It is 0.9903.Wherein, X is shading ratio, represents decimally；Y is concentration, unit mg/10ml.Will detection
Shading than and corresponding concentration convert, thus quantitatively draw the dissolution rate of granule, that learns granule further leaches situation.
The relation test leaching concentration and shading ratio of embodiment 2 Cortex Cinnamomi breaking cellular wall decoction pieces
1) Cortex Cinnamomi breaking cellular wall decoction pieces 2g is taken, accurately weighed, it is placed in 100mL beaker, is slowly added into precision along walls of beaker and measures
50mL water；
2) granule in beaker and solvent being carried out strong stirring makes granule disperse in 5 minutes；After shaking all, precision measures 0.5 the most respectively
ML, 1.0mL, 1.5mL, 2.0mL, 2.5mL, 3.0mL, 3.5mL, 4.0mL, 4.5mL, 5.0mL granule
Dispersion liquid is in 10mL volumetric flask；
3) take appropriate water constant volume, the particle dispersion after dilution added in the injector of American-European gram LS-609 laser particle analyzer,
Operate according to particle size distribution detection method, the parameter of laser particle analyzer is set, ultrasonic before disperse medium choosing " water ", measurement
30 seconds, other parameters such as index of refraction all selected default value, read shading ratio, and recorded result such as table 2 below.
Table 2
| Dispersion liquid measure | 0.5mL | 1.0mL | 1.5mL | 2.0mL | 2.5mL |
| Add the water yield | 9.5mL | 9.0mL | 8.5mL | 8.0mL | 7.5mL |
| Concentration (mg/mL) | 2.0040 | 4.0080 | 6.0120 | 8.0160 | 10.0200 |
| Shading ratio | 3.69% | 7.86% | 11.28% | 15.95% | 18.59% |
| Dispersion liquid measure | 3.0mL | 3.5mL | 4.0mL | 4.5mL | 5.0mL |
| Add the water yield | 7.0mL | 6.5mL | 6.0mL | 5.5mL | 5.0mL |
| Concentration (mg/mL) | 12.0240 | 14.0280 | 16.0320 | 18.0360 | 20.0400 |
| Shading ratio | 22.05% | 26.56% | 30.63% | 32.60% | 36.87% |
Data in table 2 are calculated, make standard curve such as accompanying drawing 2, show that linearity of regression equation is Y=546.2X-2.343,
Coefficient R2It is 0.997.Wherein, X shading ratio, represent decimally；Y is concentration, unit mg/10ml.
The relation of the time that leaches of embodiment 3 Semen Coicis breaking cellular wall decoction pieces and shading ratio is tested
1) Semen Coicis breaking cellular wall decoction pieces 4g is taken, accurately weighed, it is placed in 250mL beaker, is slowly added into precision along walls of beaker and measures
90～100 DEG C, 100mL water；
2) by granule in beaker and solvent with the clockwise direction of 2 circles per second stir 1 minute, 2 minutes, 3 minutes, 5 minutes,
After 10 minutes, stand 30 seconds, respectively in accurate volumetric flask the most different for the liquid 2.0mL measured at the 2cm of chaotropic face,
Observe particle residue situation at the bottom of cup；
3) particle dispersion is settled to 10mL, the particle dispersion after dilution is added American-European gram LS-609 laser particle analyzer
Injector in, operate according to particle size distribution detection method, the parameter of laser particle analyzer be set, disperse medium choosing " water ",
Before measuring ultrasonic 30 seconds, other parameters such as index of refraction all selected default value, read shading ratio, and record result such as table 3 below.
Table 3
As known from Table 3, mixing time is the most long, leaches degree the highest, and shading ratio is the highest.By the shading of detection frequently to correspondence
Concentration converts, thus quantitatively draws the dissolution rate of granule.Dissolution rate is the highest, leaches degree the best, thus the preparation of granule
Technique is the best.
The relation of the time that leaches of embodiment 4 Cortex Cinnamomi breaking cellular wall decoction pieces and shading ratio is tested
1) Cortex Cinnamomi breaking cellular wall decoction pieces 4g is taken, accurately weighed, it is placed in 250mL beaker, is slowly added into what precision measured along walls of beaker
90～100 DEG C, 100mL water；
2) by granule in beaker and solvent with the clockwise direction of 2 circles per second stir 1 minute, 2 minutes, 3 minutes, 5 minutes,
After 10 minutes, standing 30 seconds, the accurate liquid 2.0mL measured the 2cm of chaotropic face at is in volumetric flask respectively, observation cup
End particle residue situation；
3) particle dispersion is settled to 10mL, the particle dispersion after dilution is added American-European gram LS-609 laser particle analyzer
Injector in, operate according to particle size distribution detection method, the parameter of laser particle analyzer be set, disperse medium choosing " water ",
Before measuring ultrasonic 30 seconds, other parameters such as index of refraction all selected default value, read shading ratio, and record result such as table 4 below.
Table 4
As known from Table 4, mixing time is the most long, leaches degree the highest, and shading ratio is the highest.By the shading of detection frequently to correspondence
Concentration converts, thus quantitatively draws the dissolution rate of granule.Dissolution rate is the highest, leaches degree the best, thus the preparation of granule
Technique is the best.
Integrated embodiment 1～2 understands, and the method correlation coefficient that the present invention provides reaches more than 0.99, and linear relationship is good, shading
Than being good linear relationship with the amount leaching liquid, can embody, with shading ratio, the degree of leaching；Embodiment 3～4 understands, and leaches
Time is proportionate with shading ratio, but is not linear relationship, matches with the practical situation leached.After Criterion curve,
The energetic speed leached and degree, shading ratio is high, and it is high that corresponding granule leaches concentration, and the amount of leaching is many, the process of granule
The best.The inventive method provides touchstone to the deficiencies in the prior art, the effective accuracy ensureing detection data, contrast
The dissolution rate of variable grain advantageously ensures that the drug effect of the granule leached, and improves the controllability of product quality, is in drug development
One innovate greatly.
The method routine provided according to the present invention arranges the different parameters of laser particle analyzer, then measures shading ratio under this parameter,
Set up further according to this shading ratio and a set of leach standard；Set up the standard limits of the dissolution rate of corresponding granule, as particle requirement leaches N
Minute shading ratio is not less than M%.
The foregoing is only the preferred embodiments of the present invention, be not limited to the present invention, for those skilled in the art
For, the present invention can have various modifications and variations.All within the spirit and principles in the present invention, any amendment of being made, etc.
With replacement, improvement etc., should be included within the scope of the present invention.
Claims (8)
1. the detection method of a granule dissolution rate, it is characterised in that concrete detecting step is: 1) prepared by standard substance working solution: take
Particle diameter is that the standard substance granule of 0.1～1000 micron is placed in transparent vessel, stirs 1～20 minute prepared granule after adding solvent
Dispersion liquid, takes particle dispersion immediately to constant volume in volumetric flask, and prepared concentration is the standard substance working solution of 2～20mg/mL；
2) draw standard curve: by step 1) in preparation standard substance working solution join in laser particle analyzer injector, use
Particle size distribution detection method detection shading ratio, draws standard curve, obtains standard curve equation；3) prepared by product to be tested: take
Particle diameter is that the product to be tested granule of 0.1～1000 micron is placed in transparent vessel, as step 1) described in method process after
Prepare particle dispersion, stands 10～200 seconds, take particle dispersion to after use solvent dilution constant volume in volumetric flask, by be measured
Product press step 2) described method detection shading ratio, the shading of product to be tested is compared step 2) standard curve drawn, look for
Go out the concentration of correspondence, thus quantitatively draw the dissolution rate of granule.
The detection method of a kind of granule dissolution rate the most according to claim 1, it is characterised in that described standard substance working solution
Concentration is 2,4,6,8,10,12,14,16,18,20mg/mL；After described standard substance working solution is detected, by concentration
Draw standard curve with the relation of shading ratio, obtain the coefficient R of standard curve2More than 0.99.
The detection method of a kind of granule dissolution rate the most according to claim 1, it is characterised in that described particle size distribution detection side
The specific operation process of method is: arrange the parameter of laser particle analyzer, selects disperse medium, measures first ultrasonic 10～100 seconds, other
Parameter all selects default value, reads shading ratio.
The detection method of a kind of granule dissolution rate the most according to claim 1, it is characterised in that described standard substance granule or treat
The particle diameter of survey product granule is 1～50 micron.
The detection method of a kind of granule dissolution rate the most according to claim 1, it is characterised in that described step 1) in solvent be
Organic solvent or water.
The detection method of a kind of granule dissolution rate the most according to claim 1, it is characterised in that described step 1) middle stirring speed
Degree is per second 0.2～5 circles.
The detection method of a kind of granule dissolution rate the most according to claim 1, it is characterised in that described step 3) in take granule
It is dilute that dispersion liquid solvent dilution constant volume refers to take constant volume in liquid 0.2～5mL to the 10mL volumetric flask in chaotropic face 1～5cm
Releasing, described time of repose is 30 seconds.
The detection method of a kind of granule dissolution rate the most according to claim 1, it is characterised in that described laser particle analyzer is Europe
Meike LS-609 laser particle analyzer.
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| CN111982763A (en) * | 2020-08-17 | 2020-11-24 | 上海普康药业有限公司 | Method for determining particle size and particle size distribution of coenzyme Q10 |
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Application publication date: 20161012 |