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Quality testing methods for generic drugs

A detection method and a technology for drug quality, applied in the direction of material inspection products, testing pharmaceutical preparations, etc., can solve problems such as detection result errors, and achieve the effect of improving accuracy and sensitivity

Active Publication Date: 2017-06-23
中国人民解放军新疆军区联勤部药品仪器检验所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The invention provides a method for detecting the quality of generic drugs, which overcomes the above-mentioned deficiencies in the prior art, and can effectively solve the problem of relatively large errors in the detection results obtained by using the existing quality detection methods for generic drugs

Method used

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  • Quality testing methods for generic drugs
  • Quality testing methods for generic drugs
  • Quality testing methods for generic drugs

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1: the detection method of this imitation medicine quality, carry out as follows: the first step, measure the cumulative stripping percentage of imitation medicine different time, time uses t i Indicates that the cumulative dissolution percentage of generic drugs corresponding to different times is represented by y i Indicates that i=1,2...n; the second step, using the t obtained in the first step i and y i Determine the mathematical model y=c-exp(-a (t-Ti) b ), the fitting parameters include c, α, Ti, b, and the values ​​of c, α, Ti, and b are respectively c 0 、α 0 、Ti 0 , b 0 , put t i and y i using mathematical models After data fitting, the dissolution curve of the cumulative dissolution percentage of the generic drug is obtained; in the third step, the original drug is obtained in the mathematical model y=c-exp(-a (t-Ti) b The values ​​of c, α, Ti, b in ) are respectively c 1 、α 1 、Ti 1 , b 1 , with the original drug in the mathematical mod...

Embodiment 2

[0022] Embodiment 2: As the optimization of the above-mentioned embodiment, the generic medicine is in the mathematical model y=c-exp(-a·(t-Ti) b The fitting parameter value in ) is obtained by the following method: the first step is to establish the .m file in matlab, and the mathematical model corresponding to the .m file is y=c-exp(-a (t-Ti) b ), call the nlinfit function in matlab, give c, α, Ti and b initial values, and the initial values ​​of c, α, Ti and b are recorded as u=(c 2 ,α 2 , Ti 2 ,b 2 ); the second step, combining the initial values ​​of c, α, Ti and b and t i Call the mathematical model in the .m file y=c-exp(-a (t-Ti) b ) to obtain the predicted value of the cumulative dissolution percentage, and the predicted value of the cumulative dissolution percentage is used Indicates that i=1,2...n, then, use the nonlinear least squares method to estimate the estimated value of the fitting parameter, and use the estimated value of the fitting parameter to Ind...

Embodiment 3

[0023] Example 3: As an optimization of the above example, the original research drug in y=c-exp(-a·(t-Ti) b ) in the fitting parameter value is obtained by the following method: the first step is to set up the .m file in matlab, and the mathematical model corresponding to the .m file is y=c-exp(-a (t-Ti) b ), call the nlinfit function in matlab, give c, α, Ti and b initial values, and the initial values ​​of c, α, Ti and b are recorded as u=(c 2 ,α 2 , Ti 2 ,b 2 ); in the second step, the cumulative dissolution percentage of the original drug at different times and corresponding different times is recorded as (t i ,y i ), combining the initial values ​​of c, α, Ti and b and t i Call the mathematical model in the .m file y=c-exp(-a (t-Ti) b ) to obtain the predicted value of the cumulative dissolution percentage, and the predicted value of the cumulative dissolution percentage is used Indicates that i=1,2...n, then, use the nonlinear least squares method to estimate th...

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Abstract

The invention relates to the technical field of detection methods for drug quality, in particular to a detection method for the generic drug quality. The method comprises the steps that when two or more fitting parameters of a generic drug are out of a confidence interval of a brand-name drug, the quality of the generic drug is not similar to the quality of the brand-name drug; when three or more fitting parameters of the generic drug are within the confidence interval of the fitting parameters of the brand-name drug, the quality of the generic drug is similar to the quality of the brand-name drug. According to the detection method for the generic drug quality, the accuracy and sensitivity of a quality detection result can be improved, and therefore the quality of the generic drug can be detected; in addition, the detection method for the generic drug quality is applicable to quality detection of different drugs and drugs of different dosage forms, and therefore the application range of the detection method for the generic drug quality is enlarged.

Description

technical field [0001] The invention relates to the technical field of detection methods for drug quality, and relates to a detection method for generic drug quality. Background technique [0002] The drug dissolution curve directly reflects the law of drug dissolution behavior, that is, directly reflects the quality of the drug production process, and then to a certain extent indicates the absorption and utilization of the drug in the body. It is a common means to identify the quality of drugs in vitro. In the quality inspection process of generic drugs, the drug dissolution curve of the generic drug is obtained by fitting the measured data (accumulative drug dissolution percentage) with a mathematical model, and the drug dissolution curve of the generic drug is compared with the drug dissolution curve of the original drug. The quality of generic drugs can be judged by comparison, and the quality of generic drugs can also be judged by parameter methods such as t-test for th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/15
CPCG01N33/15
Inventor 耿东升李学强朱东亮
Owner 中国人民解放军新疆军区联勤部药品仪器检验所
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