Method for detecting and evaluating in-vitro dissolution of enteric preparation

Abstract

The invention relates to a method for detecting and evaluating in-vitro dissolution of an enteric preparation. The method is performed according to standards of Chinese Pharmacopoeia and comprises thesteps as follows: conducting a dissolution test in a simulated gastric fluid dissolution medium; then, transferring the enteric preparation in water or weakly acid dissolution medium for a dissolution test; besides, directly performing a dissolution test on the preparation in water or the weakly acid dissolution medium; comparing the difference between dissolution results of preparation subjectedto or not subjected to dissolution treatment in the simulated gastric fluid dissolution medium to determine the reliability of the enteric performance of the preparation. The method can provide datasupport for selection of multi-source reference preparations in generic drug consistency evaluation and provide reference for prescription screening and bioequivalence risk evaluation. More importantly, the method is used for detecting and evaluating in-vitro dissolution of the enteric preparation, so that the incidence rate of adverse events of clinical medication can be reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug detection method, in particular to a drug dissolution determination method and a method for evaluating related drugs by the detection method. More specifically, the present invention relates to a method for testing and evaluating the in vitro dissolution rate of enteric-coated preparations, especially enteric-coated tablets of non-steroidal anti-inflammatory drugs such as diclofenac sodium. The method of the present invention can be used to reduce the incidence of clinical drug adverse events Background technique [0002] Non-steroidal anti-inflammatory drugs have antipyretic, analgesic, and anti-inflammatory effects. They are classified according to their chemical structure. Among them, the classic drugs in the acetic acid class of non-steroidal anti-inflammatory drugs include diclofenac, which is usually used in the form of diclofenac sodium (Diclofenac Sodium) , because...

AI Technical Summary

Problems solved by technology

[0011] The present inventors have surprisingly found that certain enteric-coated preparations, such as enteric-coated tablets of certain NSAIDs such as diclofenac sodium, when using standard dissolution test methods to evaluate their in vitro dissolution performance, this evaluation When the preparation obtained by the method is clinically used for the above-mentioned patients with high pH value of gastric content, there will be hidden dangers in drug safety.