CN104977223A - Method of predicting the change of water content of traditional Chinese medicine hard capsule contents in acceleration test process - Google Patents
Method of predicting the change of water content of traditional Chinese medicine hard capsule contents in acceleration test process Download PDFInfo
- Publication number
- CN104977223A CN104977223A CN201410141037.6A CN201410141037A CN104977223A CN 104977223 A CN104977223 A CN 104977223A CN 201410141037 A CN201410141037 A CN 201410141037A CN 104977223 A CN104977223 A CN 104977223A
- Authority
- CN
- China
- Prior art keywords
- moisture absorption
- chinese medicine
- hours
- content
- accelerated test
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a method of predicting the change of water content of traditional Chinese medicine hard capsule contents in an acceleration test process, wherein the method includes the following steps: (1) drawing a moisture sorption isotherm of the traditional Chinese medicine hard capsule contents under the condition of the relative humidity being 2.5-40%; (2) with the artificial neural network algorithm, establishing a three-dimensional moisture absorption dynamic model of environmental humidity-moisture absorption-moisture absorption weight gaining of the traditional Chinese medicine hard capsule contents; (3) measuring the moisture absorption data of the contents under an acceleration test condition and introducing the moisture absorption data into the three-dimensional moisture absorption dynamic model; and (4) performing deduction of time axis of the model to calculate the water content of the traditional Chinese medicine hard capsule contents at the end point of the acceleration test. The method is simple in operations and is highly fitted with an actual measurement result. An acceleration test result after six months can be obtained just by obtaining the isothermal moisture adsorption of 48 h and the moisture absorption data under the acceleration test condition, thereby improving researching efficiency and provides an important evidence for selecting the formula of traditional Chinese medicine hard capsules.
Description
Technical field
The present invention relates to field of traditional Chinese, be specifically related to a kind of method predicting the change of moisture content of Chinese medicine hard shell capsules content in accelerated test process.
Background technology
Chinese medicine hard shell capsules usually runs into the situations such as hard shell capsules content water cut exceeds standard, hard capsule case cosmetic variation in the process stored, and has had a strong impact on the quality of hard capsule, and then has affected production marketing.
The problems referred to above are almost closely related with the hydroscopicity of Chinese medicine preparation raw material without exception, and the main cause producing these problems to be auxiliary material selected in prescription do not play the effect improving preparation raw material physical stability, meanwhile, these problems are often exposed in accelerated test process.Can't the problems referred to above be there are in just filling hard shell capsules, and accelerated test generally needs to carry out six months, therefore, when a problem occurs, be difficult to adopt remedial measures, therefore, a kind of reasonable sign Chinese medicine hard shell capsules content hydroscopicity, method by change of moisture content trend in the experiment of short time and measurable long-time accelerated test process is needed badly.
At present, the method for describing moisture absorption behavior mainly contains sorption isotherm curve, equilibrium moisture content and critical relative moisture three kinds, and three kinds of methods respectively have weak point.Sorption isotherm curve can only reflect the moisture absorption weightening finish of sample under certain single damp condition, cannot show the rate of moisture absorption change of sample under different humidity condition; Equilibrium moisture content can only reflect the Saturated Moisture Content of sample under different humidity condition, cannot reflect the change of rate of moisture absorption in moisture absorption process; Critical relative moisture only can provide Saturated Moisture Content that ambient humidity jumpy occurs, and cannot provide the change of rate of moisture absorption equally.In addition, BET model and GAB model is mainly contained for calculating the dynamic (dynamical) common mathematical model of moisture absorption.Wherein BET model is only applicable to the mono layer adsorption being greater than 50% in relative humidity.GAB model is the correction on BET model basis, is applicable to multi-molecular absorption, is applicable to humidity range widely simultaneously.But the matching of GAB model needs to carry out long-term complicated measuring process, and accumulate a large amount of experimental datas, not only fitting effect is not good, and GAB model is except providing unimolecule saturated extent of adsorption, does not provide more multilist to seek peace and evaluates hygroscopic parameter.Also scholar is had sorption isotherm curve and GAB model to be combined, matching is carried out by using the moisture absorption isothermal curve of quadratic equation with one unknown and Chinese medicine hard shell capsules content, and solve single order respectively, the method for second derivative obtains moisture-absorption characteristics parameter--the saturated moisture absorption average velocity of moisture absorption initial velocity, moisture absorption acceleration and unimolecular layer, and adopt above-mentioned parameter to describe moisture absorption dynamics (" impact of Chinese medicine preparation raw material humidity resistance " CHINA JOURNAL OF CHINESE MATERIA MEDICA 2009 of Chinese medicine hard shell capsules content, 34 (1): 35 ~ 38 Zhao Li are outstanding, Feng Yi, Xu Desheng etc.).Use these three parameters can the size of more different Chinese medicine hard shell capsules content wettability power directly perceived, the speed of rate of moisture absorption, but these three parameters be still only applicable to single damp condition.Simultaneously, due to quadratic equation with one unknown function parabolically, can only ascent stage of matching sorption isotherm curve, when moisture absorption is close to the scope beyond equation model during balance, therefore this equation cannot deduce the change of hygroscopic capacity in Chinese medicine hard shell capsules content long-time stability experimentation.
As can be seen here, the change of moisture content of above-mentioned existing hydroscopicity characterizing method all unpredictable Chinese medicine hard shell capsules content in six months accelerated test processes.
Summary of the invention
The problems referred to above existed for prior art and demand, technical matters to be solved by this invention is: provide a kind of method predicting the change of moisture content of Chinese medicine hard shell capsules content in accelerated test process, realize Chinese medicine hard shell capsules content change of moisture content trend in the experiment of short time and measurable long-time accelerated test process, for experiment and production provide reference frame.
For achieving the above object, the present invention adopts following technical scheme:
Predict a method for the change of moisture content of Chinese medicine hard shell capsules content in accelerated test process, comprise the steps:
A) measure the isothermal absorption data of Chinese medicine hard shell capsules content under relative humidity 2.5% ~ 40% condition and draw sorption isotherm curve;
Described 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;
The isothermal absorption data acquisition water vapor adsorption instrument of sample is measured, instrument temperature is set to 25 DEG C, relative humidity can select the arbitrary value in 2.5% ~ 40% scope, preferably be chosen as 2.5%, 5.0%, 10%, 15%, 20%, 25%, 30%, 35%, 40% 9 relative humidity point or part relative humidity point wherein, the T.T. of moisture absorption generally selects 48 hours, the time interval of two measurement points can select the random time being no less than 5 minutes, preferably select at 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, within 48 hours, seven time points are measured,
Concrete operation method is: get dry measuring cup (φ 25 × 25) and be placed in corresponding exsiccator balance 24 hours the previous day in experiment, the content of a capsules is got after peeling, be laid in above-mentioned measuring cup, start to measure, after terminal is measured in arrival, automatically provide sorption isotherm curve by instrument, and list the moisture absorption percent increase in weight corresponding to setting-up time point;
B) by the artificial neural network algorithm of the market demand on above-mentioned sorption isotherm curve on Matlab software, " ambient humidity-humidity exposure time-moisture absorption weightening finish " three-dimensional moisture absorption kinetic model of this Chinese medicine hard shell capsules content is set up;
First by the data of above-mentioned sorption isotherm curve stored in Excel, called after data1.xlsx; Enter Matlab interface, editor's relative program carries out computing, can obtain the corresponding three-dimensional moisture absorption kinetic model of this Chinese medicine hard shell capsules content;
Described program is:
C) the accelerated test moisture absorption data of Chinese medicine hard shell capsules content under accelerated test condition are measured;
Select suitable capsule shells, the weight of precision weighing capsule 's content, according to the filling one-tenth capsule of labelled amount, take the manner of packing of bubble-cap, two aluminium or bubble-cap+plastic-aluminum to be packed; Packaged capsule is placed in 40 DEG C ± 2 DEG C, in the climatic chamber of relative humidity 75% ± 5%, packaging is taken apart respectively within the time interval set, precision weighing capsule 's content weight, capsule 's content moisture absorption percent increase in weight when calculating the corresponding time interval, obtains accelerated test moisture absorption data;
D) follow procedure is write, the accelerated test moisture absorption data of above-mentioned Chinese medicine hard shell capsules content under accelerated test condition are introduced in " ambient humidity-humidity exposure time-moisture absorption weightening finish " three-dimensional moisture absorption kinetic model of this Chinese medicine hard shell capsules content, find out the hard shell capsules content sorption isotherm curve that degree of fitting is the highest under accelerated test condition in model, try to achieve corresponding humidity again, bring this humidity and accelerated test time into model, the sorption isotherm curve time shaft that this model-fitting degree is the highest is deduced, the water cut percentage changing value of this Chinese medicine hard shell capsules content when accelerated test terminal can be tried to achieve, this value is added with the former water cut of hard shell capsules content, the water cut of this Chinese medicine hard shell capsules content when accelerated test terminal can be drawn, accordingly, the physical stability of this Chinese medicine hard shell capsules can be judged,
Described program is:
The water cut of capsule 's content when A adds that the initial water content of capsule 's content itself can obtain accelerated test terminal; Capsule maximum water content in its water cut and " Chinese Pharmacopoeia " (version in 2010) annex rules of preparations must not be crossed compared with the regulation of 9%, if be less than 9% can judge that this capsule 's content has good physical stability.
Beneficial effect of the present invention is:
The present invention is by using for reference the Artificial Neural Network Modeling method of forefront in the world, establish the brand-new hygroscopic Forecasting Methodology of Chinese medicine hard shell capsules content, the accelerated test result after six months can be inferred by the tests of 48 hours, effectively improve now methodical shortcoming, significantly improve efficiency of research and development, for Chinese medicine hard shell capsules prescription screening provides important basis for estimation, provide reliable Data support for producing, there is higher directive significance.Further, the inventive method is simple, workable, high with the measured result goodness of fit, achieves the hope that industry wishes to predict Chinese medicine hard shell capsules content physical stability when accelerated test terminal.
Accompanying drawing explanation
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 result.
Embodiment
The present invention is illustrated further below in conjunction with embodiment.
Embodiment 1: the change of prediction Chinese gall medicinal powder hard capsule content water cut when accelerated test terminal
A) measure the isothermal absorption data of Chinese Gall under relative humidity is 2.5% ~ 40% condition and draw sorption isotherm curve;
Water vapor adsorption instrument is adopted to measure the hydroscopicity of Chinese Gall, method is: instrument temperature is set to 25 DEG C, relative humidity is set to 2.5%, 20%, 40% respectively, weighs time point and is set to 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours;
Get dry measuring cup (φ 25 × 25) and be placed in exsiccator balance 24 hours the previous day in experiment, the content of a seed lac wafer is got after peeling, be laid in above-mentioned measuring cup, put into water vapor adsorption instrument to measure, measure complete, automatically draw out isothermal absorption time curve by water vapor adsorption instrument, and list the moisture absorption percent increase in weight corresponding to setting-up time point.
Measurement result is as follows:
Table 1 Chinese gall medicinal powder ambient humidity-humidity exposure time-moisture absorption percentage weight increase measurement result
B) related data on above-mentioned sorption isotherm curve is applied in the artificial neural network algorithm of Matlab software, sets up " ambient humidity-humidity exposure time-moisture absorption weightening finish " three-dimensional moisture absorption kinetic model of Chinese gall medicinal powder;
By the data of above-mentioned sorption isotherm curve stored in Excel, called after data1.xlsx.Enter Matlab interface, edit following program, obtain the three-dimensional moisture absorption kinetic model of " ambient humidity-humidity exposure time-moisture absorption weightening finish " of Chinese gall medicinal powder;
Described program is:
C) the accelerated test moisture absorption data of Chinese gall medicinal powder hard shell capsules content under accelerated test condition are measured;
Select No. 5 gelatine capsule shell, the filling one-tenth capsule of precision weighing Chinese gall medicinal powder 0.40g, blister package; Packaged capsule is placed in 40 DEG C ± 2 DEG C, in the climatic chamber of relative humidity 75% ± 5%, packaging is taken apart respectively at 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, precision weighing Chinese gall medicinal powder, calculates moisture absorption percent increase in weight; 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 in Chinese gall medicinal powder " ambient humidity-humidity exposure time-moisture absorption weightening finish " three-dimensional moisture absorption kinetic model, find out the hard shell capsules content sorption isotherm curve that degree of fitting is the highest under accelerated test condition in this model, this plot against time axle is deduced, calculates the change of moisture content of this Chinese gall medicinal powder hard capsule content when accelerated test terminal;
Write follow procedure, by the moisture absorption percent increase in weight result 0.6% of above-mentioned measurement gained Chinese gall medicinal powder hard capsule content under accelerated test condition, 1.4%, 1.7%, 2.1%, 2.4%, 2.5%, 2.1% brings " ambient humidity-humidity exposure time-moisture absorption weightening finish " moisture absorption dynamics neural network model into, find the sorption isotherm curve that degree of fitting is the highest, try to achieve corresponding ambient humidity, bring humidity and accelerated test time into model again, moisture absorption percent increase in weight when trying to achieve Chinese gall medicinal powder hard capsule content accelerated test terminal, water cut former in it is added again, obtain the single-detector of content during accelerated test terminal,
Described program is:
Effect judges:
During prediction accelerated test terminal, the moisture absorption gain in weight of hard capsule content Chinese gall medicinal powder is 1.7%, and the water cut of former Chinese gall medicinal powder is 2.0%, and therefore during accelerated test terminal, the water cut of content should be 3.7%; This water cut is less than capsule maximum water content in " Chinese Pharmacopoeia " (version in 2010) annex rules of preparations must not cross the regulation of 9%, therefore can judge that this capsule has good physical stability.
During actual measurement accelerated test terminal, the water cut of hard capsule content Chinese gall medicinal powder is 3.5%, contrast prediction and measured result, the two difference is only 0.2%, and within the scope of acceptable test error, therefore Forecasting Methodology provided by the invention has good degree of fitting.
Embodiment 2: the change of prediction Psoralea corylifolia extract powder hard capsule content water cut when accelerated test terminal
A) measure isothermal absorption data under relative humidity is 2.5% ~ 40% condition of Psoralea corylifolia extract powder and draw sorption isotherm curve;
Method is identical with embodiment 1 with instrument, and difference is only that relative humidity is set to:
2.5%、10%、20%、30%、40%；
Measurement result is as follows:
Table 2 Psoralea corylifolia extract powder ambient humidity-humidity exposure time-moisture absorption percentage weight increase measurement result
B) related data on above-mentioned sorption isotherm curve is applied in the artificial neural network algorithm of Matlab software, sets up " ambient humidity-humidity exposure time-moisture absorption weightening finish " three-dimensional moisture absorption kinetic model of Psoralea corylifolia extract powder;
Method is identical with embodiment 1 with step, and difference is only 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 three-dimensional model of " ambient humidity-humidity exposure time-moisture absorption weightening finish " of Psoralea corylifolia extract powder can be obtained;
C) the accelerated test moisture absorption data of Psoralea corylifolia extract powder hard capsule content under accelerated test condition are measured;
Method is identical with embodiment 1 with step, difference is only the filling capsule of precision weighing Psoralea corylifolia extract powder 0.35g, and two aluminium packaging, took packaging apart respectively at 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, precision weighing Psoralea corylifolia extract powder, calculates 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 to be introduced in Psoralea corylifolia extract powder " ambient humidity-humidity exposure time-moisture absorption weightening finish " three-dimensional moisture absorption kinetic model and to deduce, calculating the water cut of Psoralea corylifolia extract powder hard capsule content when accelerated test terminal;
Method is identical with embodiment 1 with step, and difference is only to read in data and subsequent arithmetic, that is:
X
1=[2；0.3]；
X
2=[6；1.0]；
X
3=[12；1.4]；
X
4=[24；1.5]；
X
5=[48；1.1]；
Bring above-mentioned data into neural network model and solve ambient humidity
Y
1=sim(net，X
1，X
2，X
3，X
4，X
5)
Y
1=9
Ambient humidity and accelerated test time-bands are entered the moisture absorption percent increase in weight that neural network model solves test endpoint
Z
1in first input data are ambient humidities, second data is humidity exposure times
Z
1=[9；24*30*6]；
K
1=sim(net，Z
1)
Z
1=1.0
Z
1=1.0 are the moisture absorption percent increase in weight during Psoralea corylifolia extract powder hard capsule content Psoralea corylifolia extract powder accelerated test terminal of prediction.
Effect judges:
During prediction accelerated test terminal, the moisture absorption gain in weight of hard capsule content Psoralea corylifolia extract powder is 1.0%, and the water cut of former Psoralea corylifolia extract powder is 3.0%, and therefore during accelerated test terminal, the water cut of content should be 4.0%.This water cut is less than capsule maximum water content in " Chinese Pharmacopoeia " (version in 2010) annex rules of preparations must not cross the regulation of 9%, therefore can judge that this capsule has good physical stability.
During actual measurement accelerated test terminal, the water cut of hard capsule content Psoralea corylifolia medicinal extract is 4.1%, contrast prediction and measured result, the two difference is only 0.1%, and within the scope of acceptable test error, therefore Forecasting Methodology provided by the invention has good degree of fitting.
Embodiment 3: the change predicting 60% kudzu root extract powder+40%MCC101 hard capsule content water cut when accelerated test terminal
A) measure prescription be isothermal absorption data under relative humidity is 2.5% ~ 40% condition of the hard capsule content of 60% kudzu root extract powder+40%MCC101 and draw sorption isotherm curve;
Method is identical with embodiment 1 with instrument, 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:
Table 360% kudzu root extract powder+40%MCC101 ambient humidity-humidity exposure time-moisture absorption percentage weight increase measurement result
B) related data on above-mentioned sorption isotherm curve is applied in the artificial neural network algorithm of Matlab software, sets up " ambient humidity-humidity exposure time-moisture absorption weightening finish " three-dimensional moisture absorption kinetic model of 60% kudzu root extract powder+40%MCC101;
Method is identical with embodiment 1 with step, and difference is only in described program
Read in data
T=xlsread (' data1.xlsx', ' 60% kudzu root extract powder+40%MCC101', ' C1:I1'); Time
H=xlsread (' data1.xlsx', ' 60% kudzu root extract powder+40%MCC101', ' B2:B10'); Ambient humidity
R=xlsread (' data1.xlsx', ' 60% kudzu root extract powder+40%MCC101', ' C2:I10'); Moisture absorption percent increase in weight
The moisture absorption dynamics three-dimensional model of " ambient humidity-humidity exposure time-moisture absorption weightening finish " of 60% kudzu root extract powder+40%MCC101 can be obtained;
C) the accelerated test moisture absorption data of 60% kudzu root extract powder+40%MCC101 hard capsule content under accelerated test condition are measured;
Method is identical with embodiment 1 with step, difference is only the filling capsule of precision weighing 60% kudzu root extract powder+40%MCC1010.40g, bubble-cap+aluminum-plastic packaged, packaging is taken apart respectively at 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, precision weighing 60% kudzu root extract powder+40%MCC101, 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 in 60% kudzu root extract powder+40%MCC101 " ambient humidity-humidity exposure time-moisture absorption weightening finish " three-dimensional moisture absorption kinetic model, to the deduction of this plot against time axle, calculate the water cut of 60% kudzu root extract powder+40%MCC101 hard capsule content when accelerated test terminal;
Method is identical with embodiment 1 with step, and difference is only to read in data and subsequent arithmetic, that is:
X
1=[2；0.5]；
X
2=[4；0.9]；
X
3=[6；1.5]；
X
4=[8；2.3]；
X
5=[12；4.2]；
X
6=[24；13.0]；
X
7=[48；24.9]；
Bring above-mentioned data into neural network model and solve ambient humidity
Y
1=sim(net，X
1，X
2，X
3，X
4，X
5，X
6，X
7)
Y
1=7
Ambient humidity and accelerated test time-bands are entered the moisture absorption percent increase in weight that neural network model solves test endpoint
Z
1in first input data are ambient humidities, second data is humidity exposure times
Z
1=[7；24*30*6]；
K
1=sim(net，Z
1)
Z
1=37.2
Z
1=37.2 are moisture absorption percent increase in weight during 60% kudzu root extract powder+40%MCC101 hard capsule content 60% kudzu root extract powder+40%MCC101 potpourri accelerated test terminal of prediction.
Effect judges:
During prediction accelerated test terminal, the moisture absorption gain in weight of hard capsule content 60% kudzu root extract powder+40%MCC101 is 37.2%, the water cut of former 60% kudzu root extract powder+40%MCC101 potpourri is 3.8%, and therefore during accelerated test terminal, the water cut of content should be 41.0%.This water cut is greater than capsule maximum water content in " Chinese Pharmacopoeia " (version in 2010) annex rules of preparations must not cross the regulation of 9%, therefore can judge that the physical stability of this capsule is poor, this prescription cannot meet stability of drug products requirement, should screen prescription further.
During actual measurement accelerated test terminal, the water cut of hard capsule content 60% kudzu root extract powder+40%MCC101 potpourri is 41.0%, and contrast prediction and measured result, the two result is completely the same, and therefore Forecasting Methodology provided by the invention has good degree of fitting.
Above-described embodiment shows, along with the increase of sorption isotherm curve number, the quantity of its basic data of Forecasting Methodology provided by the invention also increases thereupon, Forecasting Methodology gained predict the outcome also closer to measured value, Data support more reliably can be provided for experiment or production, there is higher directive significance.
Finally be necessary described herein: above-described embodiment is only for being described in more detail technical scheme of the present invention; can not be interpreted as limiting the scope of the invention, some nonessential improvement that those skilled in the art's foregoing according to the present invention is made and adjustment all belong to protection scope of the present invention.
Claims (6)
1. predict a method for the change of moisture content of Chinese medicine hard shell capsules content in accelerated test process, it is characterized in that, comprise the steps:
A) measure the isothermal absorption data of Chinese medicine hard shell capsules content under relative humidity is 2.5% ~ 40% condition and draw sorption isotherm curve;
B) by the market demand on above-mentioned sorption isotherm curve in the artificial neural network algorithm of Matlab software, set up " ambient humidity-humidity exposure time-moisture absorption weightening finish " three-dimensional moisture absorption kinetic model of this Chinese medicine hard shell capsules content;
C) the accelerated test moisture absorption data of Chinese medicine hard shell capsules content under accelerated test condition are measured;
D) above-mentioned accelerated test moisture absorption data are introduced " ambient humidity-humidity exposure time-moisture absorption weightening finish " three-dimensional moisture absorption kinetic model of this Chinese medicine hard shell capsules content, this model time axle inputs the time of accelerated test terminal, the changing value of Chinese medicine hard shell capsules content water cut when this accelerated test terminal can be drawn.
2. the method for claim 1, is characterized in that: described 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.
3. the method for claim 1, it is characterized in that: described step a) in isothermal absorption data acquisition water vapor adsorption instrument measure, measuring tempeature is 25 DEG C, relative humidity is the arbitrary value in 2.5% ~ 40% scope, moisture absorption T.T. is 48 hours, and the time interval of two measurement points is be no less than the random time of 5 minutes.
4. the method for claim 1, is characterized in that: described step a) in isothermal absorption data be 2.5%, 5.0%, 10%, 15%, 20%, 25%, 30%, 35%, 40% or wherein part relative humidity point, the two measurement point time intervals measured under condition at 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours in relative humidity.
5. the method for claim 1, it is characterized in that: described step c) be by capsule 's content according to the filling one-tenth capsule of labelled amount and packaging is placed on 40 DEG C ± 2 DEG C, relative humidity is in the climatic chamber of 75% ± 5%, within the time interval set, take packaging apart measure.
6. method as claimed in claim 5, is characterized in that: described in be packaged as in bubble-cap, two aluminium or bubble-cap+plastic-aluminum mode any one.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410141037.6A CN104977223B (en) | 2014-04-09 | 2014-04-09 | A kind of method of change of moisture content of the prediction Chinese medicine hard shell capsules content during accelerated test |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410141037.6A CN104977223B (en) | 2014-04-09 | 2014-04-09 | A kind of method of change of moisture content of the prediction Chinese medicine hard shell capsules content during accelerated test |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104977223A true CN104977223A (en) | 2015-10-14 |
| CN104977223B CN104977223B (en) | 2017-10-24 |
Family
ID=54273943
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410141037.6A Active CN104977223B (en) | 2014-04-09 | 2014-04-09 | A kind of method of change of moisture content of the prediction Chinese medicine hard shell capsules content during accelerated test |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN104977223B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110118712A (en) * | 2019-05-16 | 2019-08-13 | 南通联亚药业有限公司 | It is a kind of for measuring the capsule and detection method of aluminum-plastic packaged moisture content Penetration ration |
| CN113109212A (en) * | 2021-03-23 | 2021-07-13 | 安徽黄山胶囊股份有限公司 | Method for establishing water migration control standard of gelatin hollow capsule |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101995891A (en) * | 2010-09-17 | 2011-03-30 | 南京工业大学 | Method for online analysis of water content of solid master batch recovery system in aromatic acid production |
| CN102109447A (en) * | 2009-12-24 | 2011-06-29 | 上海张江中药现代制剂技术工程研究中心 | Method for quickly judging hygroscopicity of traditional Chinese medicine extract powders |
-
2014
- 2014-04-09 CN CN201410141037.6A patent/CN104977223B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102109447A (en) * | 2009-12-24 | 2011-06-29 | 上海张江中药现代制剂技术工程研究中心 | Method for quickly judging hygroscopicity of traditional Chinese medicine extract powders |
| CN101995891A (en) * | 2010-09-17 | 2011-03-30 | 南京工业大学 | Method for online analysis of water content of solid master batch recovery system in aromatic acid production |
Non-Patent Citations (2)
| Title |
|---|
| 林婷婷等: "中药浸膏粉吸湿过程模型及应用研究", 《中国中药杂志》 * |
| 邢阳等: "贮存环境下塑料器件吸湿规律的神经网络预测", 《新技术新工艺》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110118712A (en) * | 2019-05-16 | 2019-08-13 | 南通联亚药业有限公司 | It is a kind of for measuring the capsule and detection method of aluminum-plastic packaged moisture content Penetration ration |
| CN110118712B (en) * | 2019-05-16 | 2022-03-08 | 南通联亚药业有限公司 | Capsule for determining moisture permeability of aluminum-plastic package and detection method |
| CN113109212A (en) * | 2021-03-23 | 2021-07-13 | 安徽黄山胶囊股份有限公司 | Method for establishing water migration control standard of gelatin hollow capsule |
| CN113109212B (en) * | 2021-03-23 | 2024-04-12 | 安徽黄山胶囊股份有限公司 | Method for formulating gelatin hollow capsule moisture migration control standard |
Also Published As
| Publication number | Publication date |
|---|---|
| CN104977223B (en) | 2017-10-24 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102824362B (en) | Medicine composition of oral rehydration salt | |
| CN103488806B (en) | For simulating dispersed method of the filler in high polymer material | |
| CN104977223A (en) | Method of predicting the change of water content of traditional Chinese medicine hard capsule contents in acceleration test process | |
| CN105560249B (en) | A kind of pharmaceutical composition containing mosapride citrate | |
| CN107260110A (en) | A kind of capsule endoscope motion control method and system | |
| CN105769905B (en) | A kind of modified-release tablets of potassium chloride and preparation method thereof | |
| CN104792461B (en) | A kind of revolving body high accuracy rotary inertia On-line Measuring Method | |
| Stegemann et al. | Application of QbD principles for the evaluation of empty hard capsules as an input parameter in formulation development and manufacturing | |
| CN111280479A (en) | Preparation method of blasting beads for improving cigarette blasting bead loading by aid of auxiliary agents | |
| CN103048409B (en) | Method for simultaneously detecting contents of four effective ingredients in antitussive tablet | |
| Wagner et al. | Rapid automated process development of a continuous capsule-filling process | |
| Pathak et al. | Localization of fluconazole in oral cavity by preferential coating of buccoadhesive tablet for treatment of oral thrush | |
| Li et al. | A novel model mouth system for evaluation of In Vitro release of nicotine from moist snuff | |
| CN105021489B (en) | A kind of method for predicting the Chinese medicine preparation safety in production time limit | |
| CN102824361B (en) | Composition containing glucose | |
| CN105055364B (en) | A kind of manufacture craft for aoxidizing hydroxypropul starch Capsules | |
| CN104188914B (en) | Amoxicillin powder and its production technology | |
| CN110118712B (en) | Capsule for determining moisture permeability of aluminum-plastic package and detection method | |
| CN104374668B (en) | A kind of quantization method of Artificial Seed Coats water conservation anti-pressure ability | |
| CN103701393A (en) | Method for compensating for torque accuracy in flux weakening of asynchronous motor | |
| CN108536995A (en) | Method and system for carrying out computer simulation test to active material on human skin | |
| CN106265731B (en) | The preparation method of ferrous sulfate matrix type sustained-release dropping pill | |
| CN107884529A (en) | A kind of method and its application for determining fat emulsion formulation entrapment efficiency | |
| CN105663090A (en) | Slow release cubic liquid crystal liquid hard capsule and preparation method thereof | |
| CN104825418B (en) | A kind of nifedipine soft capsule and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |