CN107944215A - A kind of method using line face method evaluation pharmaceutical preparation dissolution rate similarity degree - Google Patents
A kind of method using line face method evaluation pharmaceutical preparation dissolution rate similarity degree Download PDFInfo
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- CN107944215A CN107944215A CN201711227833.1A CN201711227833A CN107944215A CN 107944215 A CN107944215 A CN 107944215A CN 201711227833 A CN201711227833 A CN 201711227833A CN 107944215 A CN107944215 A CN 107944215A
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Abstract
The invention belongs to Pharmaceutical Analysis technical field, more particularly to a kind of method using line face method evaluation pharmaceutical preparation dissolution rate similarity degree.The present invention provides it is a kind of can between quantitative assessment pharmaceutical preparation dissolution rate similarity degree method, this method is by calculating the mean vector of test sample stripping curve matrix to the horse formula distance of reference preparation stripping curve matrix, to compare the similitude of test sample preparation and reference preparation stripping curve.A kind of method using line face method evaluation pharmaceutical preparation dissolution rate similarity degree provided by the invention is in the similarity degree of two kinds of preparation stripping curves of evaluation, difference in every group of experimental data group is characterized by the covariance matrix of test sample stripping curve data matrix, and the influence of this species diversity is brought into result of calculation to the end, more comprehensively reflect whole experiment process, and the experimental data of every is not only represented with average.
Description
Technical field
It is more particularly to a kind of using line face method evaluation pharmaceutical preparation dissolution rate phase the invention belongs to Pharmaceutical Analysis technical field
Like the method for degree.
Background technology
The In Vitro Dissolution degrees of data of solid pharmaceutical preparation be a kind of pharmaceutical preparation different cultivars of evaluation, different manufacturers product,
The significant data of quality between different batches.There is different requirement standards to different preparations in pharmacopoeia of each country.In Vitro Dissolution
Certain correlation is presented with vivo biodistribution availability to a certain extent in degree, often can also estimate from its In Vitro Dissolution degrees of data
Count its pharmacokinetics and the characteristic of drug bioavailability.U.S. FDA thinks some medicines to be tried with dissolution in vitro
Test and tested instead of vivo biodistribution availability.Its condition is that dissolution in vitro is related to vivo biodistribution availability：1. indicate dose
Dissolution percentage is related to body absorption percentage.2. dissolution rate and amount and pharmacokinetic parameter tmax, cmax, Ka, AUC
It is related.3. dissolution rate and amount are related to pharmacological action.4. averagely dissolution in vitro is related to average residence time.In Vitro Dissolution
Degree has the characteristics that easy, controllable, accurate, easy repeat compared with being tested with vivo biodistribution availability.Therefore mouths of the FDA in 1999
Similarity estimate is recommended in oral solid bioavailability of drugs and bioequivalence Guide to research and evaluates its dissolution rate, with true
Determine Counterfeit Item and compare the dissolution rate difference of medicine, and assert the similar factors f2 of test drug>50 be equivalent.
The paper of entitled " the statistical evaluation analysis of the dissolution in vitro of solid pharmaceutical preparation " that Xia Jinhui etc. is delivered is public
Open using f2 factorization methods to evaluate similarity degree between the stripping curve of different batches pharmaceutical preparation.Though the method has, calculating is simple,
Without fitted model parameters, the advantages that can directly calculating dissolution data, but this method is the basic data point calculated, real
It is then the parallel average value measured several times of each sample point, integral experiment data is replaced with average, the difference of data in easy group
Property, so that there is relatively large deviation in result.
The content of the invention
In order to overcome in the prior art evaluate pharmaceutical preparation between dissolution rate similarity degree method existing for deficiency, the present invention
Provide it is a kind of can between quantitative assessment pharmaceutical preparation dissolution rate similarity degree method, this method is by calculating test sample system
The mean vector of stripping curve matrix to reference preparation stripping curve matrix horse formula distance, come compare kind of test sample preparation with ginseng
Than the similitude of preparation stripping curve.The size of its distance can be used to evaluate the similarity degree of two kinds of drug-eluting curves, and value is got over
It is small, then show that two kinds of preparation stripping curve similarity degrees are higher.
The present invention provides a kind of method using line face method evaluation pharmaceutical preparation dissolution rate similarity degree, including following step
Suddenly：
The stripping curve data preparation of test sample preparation into test sample stripping curve matrix, is named as κ and sees formula 1 by S1, and
If Σ1, be its covariance matrix, every a line in matrix represents the parallel dissolution experiment data of each dissolution time point, each
Row represent each sampling time point of stripping curve,
The stripping curve data preparation of reference preparation into reference preparation stripping curve matrix λ, is shown in formula 2, and set Σ by S22、
For its covariance matrix, every a line in matrix represents the parallel dissolution experiment data of each dissolution time point, and each row represent
Each sampling time point of stripping curve,
S3 uses vector μ respectively1With μ2Carry out the average value that representing matrix κ and matrix λ often goes, see formula 4 and formula 5,
S4 calculates the horse formula distance D of vector κ to matrix λ,
D1 2=(μ2-μ1)′Σ-1(μ2-μ1) formula 5.
Wherein, 5 numerical value of formula is smaller, shows the mean vector μ of matrix κ1Horse formula distance to matrix λ is nearer, both represents two
Kind stripping curve and reference preparation stripping curve similarity degree are higher.
Compared with prior art, the method provided by the invention using line face method evaluation pharmaceutical preparation dissolution rate similarity degree
Beneficial effect includes：In the similarity degree of two kinds of preparation stripping curves of evaluation, pass through test sample stripping curve data matrix
Covariance matrix brings the influence of this species diversity into the end result of calculation to characterize the difference in every group of experimental data group
In, more comprehensively reflect whole experiment process, and the experimental data of every is not only represented with average.
Brief description of the drawings
Fig. 1 is the dispersion degree of 1 dissolution data point of test sample preparation.
Fig. 2 is the dispersion degree of 2 dissolution data point of test sample preparation.
Fig. 3 is two kinds of test sample preparations and reference preparation stripping curve.
Fig. 4 is principle of the invention ideograph.
Embodiment
Embodiment one, a kind of method using line face method evaluation pharmaceutical preparation dissolution rate similarity degree
The stripping curve data preparation of test sample preparation into test sample stripping curve matrix, is named as κ and sees formula 1 by S1, and
If Σ1, be its covariance matrix, every a line in matrix represents the parallel dissolution experiment data of each dissolution time point, each
List
Show each sampling time point of stripping curve,
The stripping curve data preparation of reference preparation into reference preparation stripping curve matrix λ, is shown in formula 2, and set Σ by S22、
Assisted for it
Variance matrix, every a line in matrix represent the parallel dissolution experiment data of each dissolution time point, each list
Show dissolution
Each sampling time point of curve,
S3 uses vector μ respectively1With μ2Carry out the average value that representing matrix κ and matrix λ often goes, see formula 4 and formula 5,
S4 calculates the horse formula distance D of vector κ to matrix λ, sees formula 5,
D1 2=(μ2-μ1)′Σ-1(μ2-μ1) formula 5.
Embodiment two, the present invention and f2 factorization methods result of calculation contrast
Respectively with f2 values method journey similar to the use line face method evaluation pharmaceutical preparation dissolution rate that the embodiment of the present invention one provides
The method of degree calculates the similarity degree of the stripping curve of two groups of test sample preparations and reference preparation, and test data comes from hydrochloric acid Paro
Western spit of fland sustained release tablets, three batch lot numbers are respectively (20140901,20140902,20140903).It is ginseng wherein with 20140901 batches
Than another two batches are tested as test sample.Experiment takes 6 sample points, and each sample point parallel determination 6 times, calculates every group
The average and relative standard deviation of sample point, are shown in Table 1.Calculated respectively with two methods, show that result of calculation is shown in Table 2.
The dissolution experimental data of 1 two kinds of test sample preparations of table and reference preparation
2 f2 methods of table and comparison of computational results of the present invention
| 0.5h | 1h | 2h | 3h | 4h | 6h | f2 | D | |
| Reference preparation | 3.96 | 7.66 | 28.03 | 51.14 | 70.24 | 95.68 | 100.0 | |
| Test sample preparation 1 | 3.17 | 8.69 | 30.77 | 52.89 | 71.01 | 93.50 | 85.1 | 2.9+e5 |
| Test sample preparation 2 | 4.27 | 11.05 | 32.99 | 53.14 | 72.65 | 93.66 | 84.5 | 7.5+e7 |
As shown in Table 2, calculated with f2 values method, the similar factors between the stripping curve of two kinds of test samples and reference preparation are almost
It is identical, but since the relative standard deviation of each sample point parallel determination data of test sample preparation 2 is larger, two groups of data it is discrete
Degree is shown in Fig. 1, Fig. 2.When application this law calculates, just symbolize otherness, D1 two orders of magnitude smaller than D2, illustrate test sample
1 with the similarity degree higher of reference preparation.
In conclusion the present invention passes through respective data matrix in the similarity degree of two kinds of preparation stripping curves of evaluation
Covariance matrix brings the influence of this species diversity into the end result of calculation to characterize the difference in every group of experimental data group
In, more comprehensively reflect whole experiment process, and the experimental data of every is not only represented with average.
Above content is that a further detailed description of the present invention in conjunction with specific preferred embodiments, it is impossible to is assert
The specific implementation of the present invention is confined to these explanations.For general technical staff of the technical field of the invention,
On the premise of not departing from present inventive concept, some simple deduction or replace can also be made, should all be considered as belonging to the present invention's
Protection domain.
Claims (6)
- A kind of 1. method using line face method evaluation pharmaceutical preparation dissolution rate similarity degree, it is characterised in that：Comprise the following steps：The stripping curve data preparation of test sample preparation into test sample stripping curve matrix, is named as κ and sees formula 1, and set Σ by S11、 For its covariance matrix, every a line in matrix represents the parallel dissolution experiment data of each dissolution time point, and each row represent Each sampling time point of stripping curve,The stripping curve data preparation of reference preparation into reference preparation stripping curve matrix λ, is shown in formula 2, and set Σ by S22, for its association Variance matrix, every a line in matrix represent the parallel dissolution experiment data of each dissolution time point, and each row represent that dissolution is bent Each sampling time point of line,S3 uses vector μ respectively1With μ2Carry out the average value that representing matrix κ and matrix λ often goes, see formula 4 and formula 5,S4 calculates the horse formula distance D of vector κ to matrix λ, sees formula 5,D1 2=(μ2-μ1)′Σ-1(μ2-μ1) formula 5.
- 2. the method according to claim 1 using line face method evaluation pharmaceutical preparation dissolution rate similarity degree, its feature exists In：Stripping curve in the step S1 includes the drug-eluting curve of ordinary preparation and the insoluble drug release song of sustained-release preparation Line.
- 3. the method according to claim 1 using line face method evaluation pharmaceutical preparation dissolution rate similarity degree, its feature exists In：Preparation in the step S1 and step S2 is solid pharmaceutical preparation, liquid preparation or special preparation.
- 4. the method according to claim 3 using line face method evaluation pharmaceutical preparation dissolution rate similarity degree, its feature exists In the solid pharmaceutical preparation is powder, granule, tablet, capsule, pill or film.
- 5. the method according to claim 3 using line face method evaluation pharmaceutical preparation dissolution rate similarity degree, its feature exists In：The liquid preparation is injection, soft capsule, ointment, suppository or aerosol.
- 6. the method according to claim 3 using line face method evaluation pharmaceutical preparation dissolution rate similarity degree, its feature exists In：The special preparation is microcapsules, microspheres agent or Liposomal agents.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104614450A (en) * | 2013-11-01 | 2015-05-13 | 天士力制药集团股份有限公司 | Fingerprint detection method of Xiaokeqing preparation |
| CN106526002A (en) * | 2016-10-12 | 2017-03-22 | 浙江工业大学 | Method for measuring content of Shenqi blood sugar reducing preparation and application thereof in overall quality control |
-
2017
- 2017-11-29 CN CN201711227833.1A patent/CN107944215A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104614450A (en) * | 2013-11-01 | 2015-05-13 | 天士力制药集团股份有限公司 | Fingerprint detection method of Xiaokeqing preparation |
| CN106526002A (en) * | 2016-10-12 | 2017-03-22 | 浙江工业大学 | Method for measuring content of Shenqi blood sugar reducing preparation and application thereof in overall quality control |
Non-Patent Citations (2)
| Title |
|---|
| YI TSONG ET AL: "STATISTICAL ASSESSMENT OF MEAN DIFFERENCES BETWEEN TWO DISSOLUTION DATA SETS", 《DRUG INFORMATION JOURNAL》 * |
| 张海龙 等: "多变量置信区间法和模型依赖法在溶出曲线相似性比较中的应用", 《药学进展》 * |
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Application publication date: 20180420 |