Quality control method for drug microtox assay system

A quality control method and drug technology, applied in the direction of measuring devices, chemiluminescence/bioluminescence, instruments, etc., can solve the problems of no quality control reference system, low detection accuracy, and difficulty in ensuring accuracy, achieving high sensitivity, High precision and accuracy, good stability

Active Publication Date: 2016-09-28
SICHUAN ACAD OF CHINESE MEDICINE SCI
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  • Application Information

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Problems solved by technology

However, because there is no quality control reference system, its detection accuracy is not high
[0004] At present, there are reports in the literature that mercuric chloride and zinc sulfate are used as toxic reference substances for detection, but a complete system has not been established, which makes it difficult to guarantee the accuracy of detection

Method used

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  • Quality control method for drug microtox assay system
  • Quality control method for drug microtox assay system
  • Quality control method for drug microtox assay system

Examples

Experimental program
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Effect test

Embodiment 1

[0029] Embodiment 1 The establishment of the quality control method of drug microtoxicity test of the present invention

[0030] 1. Establishment method of quality control system

[0031] Precisely weigh ZnSO 4 ·7H 2 O 50.0mg is placed in a 500ml volumetric flask, fully dissolved in ultrapure water, and the volume is constant to obtain 100.0mg·L -1 stock solution. The stock solution was diluted with ultrapure water to obtain a concentration of 5.0 mg·L -1 , 20.0mg·L -1 , 40.0mg·L -1 and 80.0mg·L -1 A series of solutions, and then mix each concentration standard poison with the osmotic pressure adjustment solution at 17:3 as a reference solution for drawing a standard curve;

[0032] In addition, the concentrations of 15.0mg·L can be prepared respectively -1 , 50.0mg·L -1 and 90.0mg·L -1 ZnSO 4 ·7H 2 O solution was mixed with 20% sodium chloride solution at a volume ratio of 17:3 to obtain a series of solutions as quality control sample solutions;

[0033] Vibrio f...

Embodiment 2

[0035] Example 2 Screening of the quality control method of the drug microtoxicity test of the present invention

[0036] 1. Experimental method

[0037] The six factors in the reaction conditions were investigated comprehensively by Plackett-Burman method. The experimental design with 11 factors and 2 levels was selected, and a total of 12 experiments were carried out, with B, D, F, H, and K as empty items to estimate the experimental error, and A, C, E, G, J, and L respectively representing the equilibrium time, resuscitation fluid For volume, recovery time, bacterial liquid volume, sample volume and reaction time, each factor is taken as a high or low level, and the best combination is selected based on the variance P value of each test group and the mean deviation D value of the luminescence coefficient. All operations using luminescent bacteria were completed at 15°C±1°C.

[0038] Table 1 Plackett-Burman experimental design factors and levels

[0039]

[0040] Accor...

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Abstract

The invention relates to a quality control method for a drug microtox assay system, wherein the quality control method comprises the following steps: (1) reference substance solution preparation: taking ZnSO4.7H2O, dissolving, preparing ZnSO4.7H2O solutions with the concentrations respectively of 5.0 mg.L<-1>, 20.0 mg.L<-1>, 40.0 mg.L<-1>, 80.0 mg.L<-1>, 100.0 mg.L<-1> and the like, and then respectively mixing with a 20% sodium chloride solution with the volume ratio of 17:3, to obtain a series of solutions as tested solutions of points of a standard curve; (2) test bacterial liquid preparation: taking vibrio fischeri, restoring, to obtain a test bacterial liquid, and determining the luminous intensity; and (3) detection: taking the reference substance solutions of the step (1), adding the test bacterial liquid, respectively determining the luminous intensities, drawing the standard curve, and carrying out accompanying quality control of a sample solution in the process of detection. The quality control method used for the drug microtox assay system and established by the method has the advantages of high sensitivity, high precision, high accuracy and good stability, can be used for detection of drug toxicity, and has good application prospect.

Description

technical field [0001] The invention relates to a quality control method of a drug microtoxicity test system. Background technique [0002] Drug toxicity is the most important factor affecting drug safety, therefore, it is very important to detect drug toxicity. [0003] The light-emitting bacterial drug micro-toxic acute toxicity test system has the advantages of fast response, sensitive detection, simple operation, and low cost. It has been applied to drugs, especially the rapid test of toxicity of traditional Chinese medicine injections. However, because there is no quality control reference system, its detection accuracy is not high. [0004] At present, there are reports in the literature that mercuric chloride and zinc sulfate are used as toxicity reference substances for detection, but a complete system has not been established, which makes it difficult to guarantee the accuracy of detection. Contents of the invention [0005] In order to solve the above problems,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/76
CPCG01N21/763
Inventor 赵军宁熊静悦鄢良春华桦
Owner SICHUAN ACAD OF CHINESE MEDICINE SCI
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