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1 Scope
This standard specifies the basic requirements for the experimental design of fishery pharmacokinetics and residue tests, the selection of sample analysis methods, the technical requirements for confirmation, the fitting of pharmacokinetic curves, the determination of models, and the estimation of parameter.
This standard applies to the metabolic kinetics and residue tests of fishery drugs in fish and shrimp; the pharmacokinetics and residue tests of other aquatic animals can be used for referenc.
2 Basic requirements for experimental design
1 Experimental fishing drugs
The generic name, content, dosage form, manufacturer, batch number, storage conditions and preparation method of fishery drugs should be give.
2 Experimental animals
1 Basic requirements
The Chinese name, Latin name and quantity, specification (body weight, body length), source, et.
2 Quantity
The parallel samples at each sampling time point are not less than 8, and the sex ratio of animals with gender differentiation should be 1:1.
3 Feeding and management
The water temperature should be kept basically stable, and the feed and breeding environment (including water temperature, salinity, dissolved oxygen, inorganic nitrogen, water size, et.
3 Dosage
The dose used in the fishery pharmacokinetics research is the effective dose used in the pharmacodynamics study, and three dose groups of high, medium and low can also be se.
4 Route of administration
Oral irrigation, mixed feeding, medicated bath, intramuscular injection and intravenous injection can be used, and food should be stopped for more than 12 hours before administratio.
5 Dosing times
It can be in the form of single administration or multiple administrations, and multiple administrations should satisfy one treatment cycl.
6 Sampling
1 Determination of sampling time point
The design of the sampling time point should include the absorption phase, the equilibrium phase (near the peak concentration) and the elimination phase of the dru.
2 Determination of sampling organization
Sampling tissues for pharmacokinetics and residue studies include blood, muscle, liver, kidney, skin and carp, et.
3 Sampling method
When collecting blood samples, fish blood can be collected by tail-dangling blood or tail vein blood; shrimp blood can be collected by heart and sinusoidal bloo.
4 Sample storage conditions
The collected tissue samples should be frozen and stored after packagin.
3 Selection of sample analysis methods
The pharmaceutical analysis methods of biological samples include chromatography, radionuclide labeling, immunology and microbiology methods, and the determination method with good specificity and high sensitivity should be selected according to the nature of the experimental animal.