CN104977223B - A kind of method of change of moisture content of the prediction Chinese medicine hard shell capsules content during accelerated test - Google Patents
A kind of method of change of moisture content of the prediction Chinese medicine hard shell capsules content during accelerated test Download PDFInfo
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Abstract
The invention discloses a kind of method of change of moisture content of prediction Chinese medicine hard shell capsules content during accelerated test, methods described include draw Chinese medicine hard shell capsules content relative humidity be 2.5%~40% under the conditions of sorption isotherm curve and apply artificial neural network algorithm, set up " ambient humidity-humidity exposure time-moisture absorption weightening " three-dimensional moisture absorption kinetic model of the Chinese medicine hard shell capsules content, by measuring the content in the hygroscopicity data under the conditions of accelerated test and being introduced into its three-dimensional moisture absorption kinetic model, then to the deduction of the model time axle, calculate the water content of Chinese medicine hard shell capsules content in accelerated test terminal.The present invention is simple to operate, it is high with the measured result goodness of fit, accelerated test result of the sample after the moisture absorption data under the conditions of the isothermal absorption and accelerated test of 48 hours can be inferred six months is only needed, efficiency of research and development is improved, important evidence is provided for Chinese medicine hard shell capsules prescription screening.
Description
Technical field
The present invention relates to field of traditional Chinese, and in particular to one kind prediction Chinese medicine hard shell capsules content is in accelerated test process
In change of moisture content method.
Background technology
Chinese medicine hard shell capsules are frequently run onto that hard shell capsules content water content is exceeded, hard capsule case outward appearance becomes during storage
Situations such as change, the quality of hard capsule is had a strong impact on, and then influence production marketing.
Hygroscopicity of the above mentioned problem almost without exception with Chinese medicine preparation raw material is closely related, and produces the master of these problems
It is that the auxiliary material selected in prescription does not play a part of improving preparation raw material physical stability to want reason, meanwhile, these problems
Often it is exposed to during accelerated test.Just filling hard shell capsules are not in above mentioned problem, and accelerated test generally require into
Row six months, has been difficult to adopt remedial measures when a problem occurs therefore, therefore, has needed a kind of rationally sign Chinese medicine hard shell capsules badly
Content hygroscopicity, the side by change of moisture content trend during the i.e. predictable long-time accelerated test of experiment of short time
Method.
Being presently used for describing the method for moisture absorption behavior mainly has sorption isotherm curve, equilibrium moisture content and critical phase to wet
Three kinds of degree, three kinds of methods respectively have weak point.Sorption isotherm curve can only reflect that the moisture absorption of sample under certain single damp condition increases
Weight, it is impossible to show the rate of moisture absorption change of sample under the conditions of different humidity；Equilibrium moisture content can only reflect under the conditions of different humidity
The Saturated Moisture Content of sample, it is impossible to reflect the change of rate of moisture absorption in moisture absorption process；Critical relative moisture is only capable of providing saturation suction
Ambient humidity jumpy occurs for moisture, can not equally provide the change of rate of moisture absorption.In addition, for calculating moisture absorption dynamics
Common mathematical modeling mainly have BET models and GAB models.Wherein BET models are only applicable to be more than in relative humidity 50% list
Molecular layer adsorption.GAB models are the amendments on the basis of BET models, it is adaptable to multi-molecular absorption, while suitable for more extensive
Humidity range.However, the fitting of GAB models needs to carry out long-term complicated measurement process, substantial amounts of experimental data is accumulated, no
Only fitting effect is not good, and GAB models are in addition to unimolecule saturated extent of adsorption is provided, and does not provide more signs and evaluates moisture absorption
The parameter of property.Sorption isotherm curve and GAB models are combined by some scholars, by with quadratic equation with one unknown and Chinese medicine ebonite
Intracapsular tolerant moisture absorption isothermal curve is fitted, and solution single order, the method for second dervative obtain moisture-absorption characteristics ginseng respectively
Number -- moisture absorption initial velocity, moisture absorption acceleration and monolayer saturation moisture absorption average speed, and Chinese medicine is described using above-mentioned parameter
The moisture absorption dynamics of hard shell capsules content（《The influence of Chinese medicine preparation raw material humidity resistance》CHINA JOURNAL OF CHINESE MATERIA MEDICA 2009,34
(1):35~38 Zhao Li are outstanding, Feng Yi, Xu Desheng etc.）.Can be with the different Chinese medicine hard shell capsules contents of intuitively comparing with these three parameters
The size of thing wettability power, the speed of rate of moisture absorption, but these three parameters are still only applicable to single damp condition.Meanwhile, by
In quadratic equation with one unknown function parabolically, the ascent stage of sorption isotherm curve can only be fitted, when moisture absorption close to balance when
Beyond the scope of equation model, therefore the equation can not deduce suction in Chinese medicine hard shell capsules content long-time stability experimentation
The change of moisture.
As can be seen here, the unpredictable Chinese medicine hard shell capsules content of above-mentioned existing hygroscopicity characterizing method added at six months
Change of moisture content in fast process of the test.
The content of the invention
In view of the above-mentioned problems existing in the prior art and demand, the technical problems to be solved by the invention are：There is provided a kind of
The method for predicting change of moisture content of the Chinese medicine hard shell capsules content during accelerated test, realizes that the experiment of short time can be pre-
Survey long-time accelerated test during Chinese medicine hard shell capsules content change of moisture content trend, for test and produce provide with reference to according to
According to.
To reach above-mentioned purpose, the present invention is adopted the following technical scheme that：
A kind of method of change of moisture content of prediction Chinese medicine hard shell capsules content during accelerated test, including following step
Suddenly：
A) the isothermal absorption data and drafting of measurement Chinese medicine hard shell capsules content under the conditions of relative humidity 2.5%~40% etc.
Warm sucting wet curve；
The Chinese medicine hard shell capsules content is Chinese drugs powder, traditional Chinese medicinal extract powder or the Chinese patent drug powder according to prescription dispensing
End；
The isothermal absorption data of sample are measured using water vapor adsorption instrument, and instrument temperature is set to 25 DEG C, relatively wet
The arbitrary value in the range of 2.5%~40% may be selected in degree, preferably selection for 2.5%, 5.0%, 10%, 15%, 20%, 25%, 30%,
35%th, 40% 9 relative humidity point or relative humidity point in part therein, moisture absorption are typically chosen 48 hours total time, two measurements
The time interval of point may be selected no less than the random time of 5 minutes, preferably select 2 hours, 4 hours, 6 hours, 8 hours,
12 hours, 24 hours, 48 hours seven time points measured；
Concrete operation method is：Take dry measuring cup（φ25×25）It is placed in corresponding drier and puts down in experiment the previous day
Weighing apparatus 24 hours, takes the content of a capsule, is laid in above-mentioned measuring cup after peeling, start measurement, and terminal is measured when reaching
Afterwards, sorption isotherm curve is provided by instrument automatically, and lists the moisture absorption percent increase in weight corresponding to setting time point；
B) by the data application on above-mentioned sorption isotherm curve in the artificial neural network algorithm on Matlab softwares, build
Erect " ambient humidity-humidity exposure time-moisture absorption weightening " three-dimensional moisture absorption kinetic model of the Chinese medicine hard shell capsules content；
The data of above-mentioned sorption isotherm curve are stored in Excel first, data1.xlsx is named as；Into Matlab circle
Face, editor's relative program carries out computing, you can obtain the corresponding three-dimensional moisture absorption kinetic model of the Chinese medicine hard shell capsules content；
Described program is：
C) accelerated test moisture absorption data of the measurement Chinese medicine hard shell capsules content under the conditions of accelerated test；
Suitable capsule shells are selected, the weight of precision weighing capsule 's content is filling into capsule according to labelled amount, takes
The manner of packing of bubble-cap, double aluminium or bubble-cap+plastic-aluminum is packed；Packaged capsule is placed in 40 DEG C ± 2 DEG C, relative humidity
In 75% ± 5% climatic chamber, packaging, precision weighing capsule 's content weight are taken apart in the time interval set respectively
Amount, capsule 's content moisture absorption percent increase in weight when calculating corresponding time interval obtains accelerated test moisture absorption data；
D) following procedure is write, by accelerated test hygroscopic number of the above-mentioned Chinese medicine hard shell capsules content under the conditions of accelerated test
According in " ambient humidity-humidity exposure time-moisture absorption weightening " that is introduced into the Chinese medicine hard shell capsules content three-dimensional moisture absorption kinetic model,
Hard shell capsules content degree of fitting highest sorption isotherm curve under the conditions of accelerated test in model is found out, then is tried to achieve corresponding
Humidity, brings this humidity and accelerated test time into model, on the model-fitting degree highest sorption isotherm curve time shaft
Deduced, you can water content percentage changing value of the Chinese medicine hard shell capsules content in accelerated test terminal is tried to achieve, by this value
It is added with the former water content of hard shell capsules content, you can show that the Chinese medicine hard shell capsules content is aqueous in accelerated test terminal
Amount, accordingly, it can be determined that the physical stability of the Chinese medicine hard shell capsules；
Described program is：
A is the aqueous of capsule 's content when can obtain accelerated test terminal plus the initial water content of capsule 's content in itself
Amount；By its water content with《Chinese Pharmacopoeia》（Version in 2010）Capsule maximum water content must not cross 9% in one annex rules of preparations
Regulation compare, if less than 9% i.e. can determine whether that the capsule 's content has good physical stability.
The beneficial effects of the present invention are：
Artificial Neural Network Modeling method of the invention by using for reference forefront in the world, establishes brand-new Chinese medicine ebonite
Intracapsular tolerant hygroscopic Forecasting Methodology, is the accelerated test result it can be inferred that after six months by the experiment of 48 hours, has
Effect improves the shortcoming of existing method, and efficiency of research and development greatly improved, and provides and important sentences for Chinese medicine hard shell capsules prescription screening
Disconnected foundation, provides reliable data for production and supports, with higher directive significance.Also, the inventive method is simple, can grasp
The property made is strong, high with the measured result goodness of fit, realizes industry and wants to prediction Chinese medicine hard shell capsules content at accelerated test end
The hope of physical stability during point.
Brief description of the drawings
Fig. 1 is Chinese gall medicinal powder ambient humidity-humidity exposure time-moisture absorption percentage weight increase measurement result；
Fig. 2 is psoralea corylifolia extract powder ambient humidity-humidity exposure time-moisture absorption percentage weight increase measurement result；
Fig. 3 is 60% kudzu root extract powder+40%MCC101 ambient humidity-humidity exposure time-moisture absorption percentage weight increase measurement results.
Embodiment
With reference to embodiment, the present invention is furture elucidated.
Embodiment 1：Predict the change of Chinese gall medicinal powder hard capsule content water content in accelerated test terminal
A) measurement Chinese Gall relative humidity be 2.5%~40% under the conditions of isothermal absorption data and draw isothermal inhale
Wet curve；
The hygroscopicity of Chinese Gall is measured using water vapor adsorption instrument, method is：Instrument temperature is set to 25 DEG C, relatively
Humidity is respectively set to 2.5%, 20%, 40%, weigh time point be set to 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24
Hour, 48 hours；
Take dry measuring cup（φ25×25）It is placed in drier and balances 24 hours in experiment the previous day, one is taken after peeling
The content of grain capsule, is laid in above-mentioned measuring cup, is put into water vapor adsorption instrument and measures, measurement is finished, and is steamed by water
Gas adsorption instrument draws out isothermal absorption time graph automatically, and lists the moisture absorption percent increase in weight corresponding to setting time point.
Measurement result is as follows：
The Chinese gall medicinal powder ambient humidity-humidity exposure time-moisture absorption percentage weight increase measurement result of table 1
B) related data on above-mentioned sorption isotherm curve is applied in the artificial neural network algorithm of Matlab softwares,
Set up " ambient humidity-humidity exposure time-moisture absorption weightening " three-dimensional moisture absorption kinetic model of Chinese gall medicinal powder；
By in the data deposit Excel of above-mentioned sorption isotherm curve, data1.xlsx is named as.Into Matlab interfaces,
Following program is edited, the three-dimensional moisture absorption power of " ambient humidity-humidity exposure time-moisture absorption weightening " of Chinese gall medicinal powder is obtained
Learn model；
Described program is：
C) accelerated test moisture absorption data of the measurement Chinese gall medicinal powder hard shell capsules content under the conditions of accelerated test；
No. 5 gelatine capsule shells are selected, precision weighing Chinese gall medicinal powder 0.40g is filling into capsule, blister package；Will
Packaged capsule is placed in 40 DEG C ± 2 DEG C, in the climatic chamber of relative humidity 75% ± 5%, respectively at 2 hours, 4 hours, 6
Hour, take within 8 hours, 12 hours, 24 hours, 48 hours packaging apart, precision weighing Chinese gall medicinal powder calculates moisture absorption and increases weight hundred
Divide ratio；Moisture absorption percent increase in weight measurement result is：0.6%、1.4%、1.7%、2.1%、2.4%、2.5%、2.1%；
D) above-mentioned accelerated test moisture absorption data are introduced into Chinese gall medicinal powder " ambient humidity-humidity exposure time-moisture absorption increasing
In the three-dimensional moisture absorption kinetic model of weight ", hard shell capsules content degree of fitting highest under the conditions of accelerated test in the model is found out
Sorption isotherm curve, is deduced on the plot against time axle, is calculated the Chinese gall medicinal powder hard capsule and is being accelerated to try
The change of moisture content of content when testing terminal；
Following procedure is write, by Chinese gall medicinal powder hard capsule content obtained by above-mentioned measurement in accelerated test condition
Under moisture absorption percent increase in weight result 0.6%, 1.4%, 1.7%, 2.1%, 2.4%, 2.5%, 2.1% bring into " during ambient humidity-moisture absorption
Between-moisture absorption weightening " moisture absorption dynamics neural network model, degree of fitting highest sorption isotherm curve is found, corresponding ring is tried to achieve
Border humidity, then bring humidity and accelerated test time into model, try to achieve Chinese gall medicinal powder hard capsule content and accelerate examination
Moisture absorption percent increase in weight when testing terminal, then be added with its former water content, the percentage of content is aqueous when producing accelerated test terminal
Amount；
Described program is：
Effect judges：
The moisture absorption gain in weight of hard capsule content Chinese gall medicinal powder is 1.7% when predicting accelerated test terminal, original five
The water content of gall nut medicinal powder is 2.0%, therefore the water content of content should be 3.7% during accelerated test terminal；The water content
It is less than《Chinese Pharmacopoeia》（Version in 2010）Capsule maximum water content must not cross 9% regulation in one annex rules of preparations, therefore
It may determine that the capsule has good physical stability.
The water content of hard capsule content Chinese gall medicinal powder is 3.5% when surveying accelerated test terminal, contrast prediction
With measured result, the two difference is only 0.2%, in the range of acceptable test error, therefore the Forecasting Methodology that the present invention is provided
With good degree of fitting.
Embodiment 2：Predict the change of psoralea corylifolia extract powder hard capsule content water content in accelerated test terminal
A) measurement psoralea corylifolia extract powder relative humidity be 2.5%~40% under the conditions of isothermal absorption data and draw isothermal
Sucting wet curve；
Method and instrument are same as Example 1, and difference is only that relative humidity is set to：
2.5%、10%、20%、30%、40%；
Measurement result is as follows：
The psoralea corylifolia extract powder ambient humidity-humidity exposure time-moisture absorption percentage weight increase measurement result of table 2
B) related data on above-mentioned sorption isotherm curve is applied in the artificial neural network algorithm of Matlab softwares,
Set up " ambient humidity-humidity exposure time-moisture absorption weightening " three-dimensional moisture absorption kinetic model of psoralea corylifolia extract powder；
Method and steps is same as Example 1, and difference is only that in described program
Read in data
T=xlsread (' data1.xlsx', ' psoralea corylifolia extract powder ', ' C1:I1')；Time
H=xlsread (' data1.xlsx', ' psoralea corylifolia extract powder ', ' B2:B6')；Ambient humidity
R=xlsread (' data1.xlsx', ' psoralea corylifolia extract powder ', ' C2:I6')；Moisture absorption percent increase in weight
The moisture absorption dynamics that " ambient humidity-humidity exposure time-moisture absorption weightening " of psoralea corylifolia extract powder can be obtained is three-dimensional
Model；
C) accelerated test moisture absorption data of the measurement psoralea corylifolia extract powder hard capsule content under the conditions of accelerated test；
Method and steps is same as Example 1, and difference is only that the filling capsules of precision weighing psoralea corylifolia extract powder 0.35g,
Double aluminium packaging, packaging is taken apart respectively at 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, precision weighing psoralea corylifolia extract powder,
Calculate moisture absorption percent increase in weight；Moisture absorption percent increase in weight measurement result is：0.3%、1.0%、1.4%、1.5%、1.1%；
D) above-mentioned accelerated test moisture absorption data are introduced into psoralea corylifolia extract powder " ambient humidity-humidity exposure time-moisture absorption increasing
In the three-dimensional moisture absorption kinetic model of weight " and deduced, calculate psoralea corylifolia extract powder hard capsule in accelerated test terminal
The water content of content；
Method and steps is same as Example 1, differs only in reading data and subsequent arithmetic, i.e.,：
X1=[2；0.3]；
X2=[6；1.0]；
X3=[12；1.4]；
X4=[24；1.5]；
X5=[48；1.1]；
Above-mentioned data band is entered into neural network model and solves ambient humidity
Y1=sim (net, X1, X2, X3, X4, X5)
Y1=9
Ambient humidity and accelerated test time-bands are entered into the moisture absorption percent increase in weight that neural network model solves test endpoint
Z1In first input data be ambient humidity, second data is humidity exposure time
Z1=[9；24*30*6]；
K1=sim (net, Z1)
Z1=1.0
Z1=1.0 be prediction psoralea corylifolia extract powder hard capsule content psoralea corylifolia extract powder accelerated test terminal when
Moisture absorption percent increase in weight.
Effect judges：
The moisture absorption gain in weight of hard capsule content psoralea corylifolia extract powder is 1.0%, former Psoralen when predicting accelerated test terminal
The water content of fat extract powder is 3.0%, therefore the water content of content should be 4.0% during accelerated test terminal.The water content is less than
《Chinese Pharmacopoeia》（Version in 2010）Capsule maximum water content must not cross 9% regulation in one annex rules of preparations, therefore can be with
Judge that the capsule has good physical stability.
The water content of hard capsule content psoralea corylifolia medicinal extract is 4.1% when surveying accelerated test terminal, and contrast is predicted and real
Result is surveyed, the two difference is only 0.1%, in the range of acceptable test error, therefore the Forecasting Methodology that the present invention is provided has
Good degree of fitting.
Embodiment 3：Predict that 60% kudzu root extract powder+40%MCC101 hard capsules content in accelerated test terminal is aqueous
The change of amount
A) the hard capsule content that measurement prescription is 60% kudzu root extract powder+40%MCC101 relative humidity be 2.5%~
Isothermal absorption data under the conditions of 40% simultaneously draw sorption isotherm curve；
Method and instrument are same as Example 1, and difference is only that relative humidity is set to：
2.5%、5%、10%、15%、20%、25%、30%、35%、40%。
Measurement result is as follows：
Kudzu root extract powder+40%MCC101 ambient humidity-humidity exposure time-moisture absorption percentage weight increase the measurement results of table 360%
B) related data on above-mentioned sorption isotherm curve is applied in the artificial neural network algorithm of Matlab softwares,
Set up 60% kudzu root extract powder+40%MCC101 " ambient humidity-humidity exposure time-moisture absorption weightening " three-dimensional moisture absorption kinetic simulation
Type；
Method and steps is same as Example 1, and difference is only that in described program
Read in data
T=xlsread (' data1.xlsx', the kudzu root extract powder+40%MCC101' of ' 60%, ' C1:I1')；Time
H=xlsread (' data1.xlsx', the kudzu root extract powder+40%MCC101' of ' 60%, ' B2:B10')；Ambient humidity
R=xlsread (' data1.xlsx', the kudzu root extract powder+40%MCC101' of ' 60%, ' C2:I10')；Moisture absorption weightening hundred
Divide ratio
The moisture absorption of 60% kudzu root extract powder+40%MCC101 " ambient humidity-humidity exposure time-moisture absorption weightening " can be obtained
Dynamics threedimensional model；
C) accelerated test of the 60% kudzu root extract powder+40%MCC101 hard capsule contents of measurement under the conditions of accelerated test
Moisture absorption data；
Method and steps is same as Example 1, and difference is only that the kudzu root extract powder+40% of precision weighing 60%
The filling capsules of MCC1010.40g, bubble-cap+aluminum-plastic packaged, respectively at 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, it is 24 small
When, take within 48 hours packaging apart, the kudzu root extract powder+40%MCC101 of precision weighing 60% calculates moisture absorption percent increase in weight；
Moisture absorption percent increase in weight measurement result is：0.5%、0.9%、1.5%、2.3%、4.2%、13.0%、24.9%；
D) above-mentioned accelerated test moisture absorption data are introduced into 60% kudzu root extract powder+40%MCC101 " during ambient humidity-moisture absorption
Between-moisture absorption weightening " in three-dimensional moisture absorption kinetic model, the deduction to the plot against time axle, calculate 60% kudzu root extract powder+
The water content of 40%MCC101 hard capsules content in accelerated test terminal；
Method and steps is same as Example 1, differs only in reading data and subsequent arithmetic, i.e.,：
X1=[2；0.5]；
X2=[4；0.9]；
X3=[6；1.5]；
X4=[8；2.3]；
X5=[12；4.2]；
X6=[24；13.0]；
X7=[48；24.9]；
Above-mentioned data band is entered into neural network model and solves ambient humidity
Y1=sim (net, X1, X2, X3, X4, X5, X6, X7)
Y1=7
Ambient humidity and accelerated test time-bands are entered into the moisture absorption percent increase in weight that neural network model solves test endpoint
Z1In first input data be ambient humidity, second data is humidity exposure time
Z1=[7；24*30*6]；
K1=sim (net, Z1)
Z1=37.2
Z1=37.2 kudzu root extract powder of 60% kudzu root extract powder+40%MCC101 hard capsules content 60% as predicted+
Moisture absorption percent increase in weight during 40%MCC101 mixture accelerated test terminals.
Effect judges：
Kudzu root extract powder+the 40%MCC101 of hard capsule content 60% moisture absorption gain in weight is during prediction accelerated test terminal
37.2%, the water content of former 60% kudzu root extract powder+40%MCC101 mixtures is 3.8%, therefore content during accelerated test terminal
Water content should be 41.0%.The water content is more than《Chinese Pharmacopoeia》（Version in 2010）Capsule is most in one annex rules of preparations
High-moisture must not cross 9% regulation, therefore may determine that the physical stability of the capsule is poor, and it is steady that the prescription can not meet medicine
Qualitative requirement, should further screen prescription.
The water content of the kudzu root extract powder+40%MCC101 mixtures of hard capsule content 60% when surveying accelerated test terminal
For 41.0%, contrast prediction and measured result, the two result are completely the same, thus the Forecasting Methodology that provides of the present invention have it is good
Degree of fitting.
Above-described embodiment shows, with the increase of sorption isotherm curve number, its basis of the Forecasting Methodology that the present invention is provided
The quantity of data is consequently increased, predicting the outcome also closer to measured value obtained by Forecasting Methodology, for experiment or can be produced
There is provided relatively reliable data to support, with higher directive significance.
Finally be necessary described herein be：Above-described embodiment is served only for making further detailed to technical scheme
Ground explanation, it is impossible to be interpreted as limiting the scope of the invention, those skilled in the art is according to the above of the invention
Some the nonessential modifications and adaptations made belong to protection scope of the present invention.
Claims (4)
1. a kind of method of change of moisture content of prediction Chinese medicine hard shell capsules content during accelerated test, it is characterised in that
Comprise the following steps：
A) the isothermal absorption data and drafting of measurement Chinese medicine hard shell capsules content under the conditions of relative humidity is 2.5%~40% etc.
Warm sucting wet curve；Wherein, isothermal absorption data are measured using water vapor adsorption instrument, and measurement temperature is 25 DEG C, relative humidity
For the arbitrary value in the range of 2.5%~40%, moisture absorption total time is 48 hours, and the time interval of two measurement points is no less than 5 points
The random time of clock；
B) by the data application on above-mentioned sorption isotherm curve in the artificial neural network algorithm of Matlab softwares, set up in this
" ambient humidity-humidity exposure time-moisture absorption weightening " three-dimensional moisture absorption kinetic model of medicine hard shell capsules content；
C) accelerated test moisture absorption data of the Chinese medicine hard shell capsules content under the conditions of accelerated test are measured, concrete operations are：By glue
It is intracapsular tolerant filling into the constant temperature for 40 DEG C ± 2 DEG C being placed in after capsule and packaging, relative humidity is 75% ± 5% according to labelled amount
In constant humidity cabinet, in the time interval set taking packaging apart measures；
D) above-mentioned accelerated test moisture absorption data are introduced to " the ambient humidity-humidity exposure time-moisture absorption of the Chinese medicine hard shell capsules content
The three-dimensional moisture absorption kinetic model of weightening ", inputs the time of accelerated test terminal, you can show that Chinese medicine is hard on the model time axle
The changing value of capsule 's content water content in the accelerated test terminal.
2. the method as described in claim 1, it is characterised in that：The Chinese medicine hard shell capsules content is Chinese drugs powder, Chinese medicine
Extract powder or the Chinese patent drug powder according to prescription dispensing.
3. the method as described in claim 1, it is characterised in that：Isothermal absorption data in the step a) are in relative humidity
2.5%th, 5.0%, 10%, 15%, 20%, 25%, 30%, 35%, 40% or when which part relative humidity point, two measurement points
Between be spaced in 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours under the conditions of measure.
4. the method as described in claim 1, it is characterised in that：It is described to be packaged as in bubble-cap, double aluminium or bubble-cap+plastic-aluminum mode
Any one.
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| 中药浸膏粉吸湿过程模型及应用研究;林婷婷等;《中国中药杂志》;20100430;第35卷(第7期);第847-851页 * |
| 贮存环境下塑料器件吸湿规律的神经网络预测;邢阳等;《新技术新工艺》;20081130(第11期);第24-27页 * |
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