Double-membrane filtration method for microbiological testing of pharmaceuticals

Abstract

The invention relates to a double-membrane filtration method for microbial inspection of pharmaceuticals. Two-layer filter membranes are used. The pore size of the first filter membrane can be 5 μm-10 μm, 10 μm-20 μm, 20 μm-30 μm, and 30 μm-50 μm. Insoluble substances such as macromolecular matrix, particles, fibers, and drug residues; the pore size of the second filter membrane is not greater than 0.45 μm, which is used to retain microorganisms. The method of the invention can effectively prevent the clogging of the filter membrane, is beneficial to eliminate the antibacterial activity of the test product, and avoids the damage of the polluting microorganisms in the test product. The method of the present invention can be used to test the medicines that cannot be effectively tested by the current method. It is proved by a large number of test data that the method is simple and feasible, and the result is effective.

Description

technical field [0001] The invention relates to the field of drug microbiological testing, in particular to a double-membrane filtration method for drug microbiological testing. Background technique [0002] Microbial contamination is one of the main causes of adverse drug events. Preventing contaminated drugs from entering the market is of great significance for ensuring the safety of patients. In the microbiological inspection of pharmaceuticals, whether the microorganisms in the microcosm can be detected, the inspection method is very important. Membrane filtration technology is an important technology for collecting microorganisms in the field of pharmaceutical microbial inspection. For drugs with antibacterial activity, it is necessary to use membrane filtration to fully eliminate the antibacterial activity of the drug, so as to facilitate the recovery, reproduction and detection of dormant or damaged microorganisms in the drug. However, there are certain defects in t...

AI Technical Summary

Problems solved by technology

However, there are certain defects in this technology at present: some drug test solutions contain carbomer, cellulose derivatives, colloidal silicon, calcium soap and insoluble drug residues, etc., often block the filter membrane during the test (the national standard stipulates that the filter Membrane pore size is not greater than 0.45μm), which makes the test unable to continue

However, due to the flaws in the method, some of the drugs contaminated by microorganisms, especially the low-level contamination, passed the test results and entered the clinic, posing a serious threat to the health of patients and even their lives.

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