Method for testing sealing integrity of medicine packaging container by improved color water intrusion method

Abstract

The invention provides a method for testing the sealing integrity of a medicine packaging container by an improved color water intrusion method, and particularly relates to the technical field of sample pretreatment of medicines. The method comprises the steps of preparing a 1% sodium fluorescein solution, and putting the 1% sodium fluorescein solution into a sealing cavity of a sealing tester; inverting a prepared positive sample, submerging an inserted capillary tube by sterile powder, keeping the capillary tube immersed in a dye solution, and tightly covering the sealing cavity; and takingout the inverted positive sample after the invasion procedure is finished; adopting a sodium hydroxide solution with a concentration of 1 [mu] g / mL as a diluent; taking sterile powder for injection, which is not subjected to capillary insertion and color water invasion, fully redissolving the sterile powder by using the diluent, transferring the sterile powder into a clean centrifuge tube, and fixing the volume to 20mL; after the invasion procedure is finished, fully redissolving each bottle by using the diluent, transferring into a clean centrifuge tube, and fixing the volume to 20mL; and observing the dye invasion condition by naked eyes. According to the invention, the sensitivity of naked eye observation and detection can be significantly improved, the specificity is high, the anti-interference ability is strong, the detection efficiency is high, and the labor cost is saved.

Description

technical field [0001] The invention belongs to the technical field of drug sample pretreatment, and in particular relates to a method for testing the integrity of the seal of a drug packaging container by an improved color water intrusion method. Background technique [0002] On October 21, 2020, the Center for Drug Evaluation (CDE) of the State Drug Administration issued the "Technical Guidelines for the Sealability Research of Chemical Drug Injection Packaging Systems (Trial)", which requires: "Injection stability testing should be conducted without Bacteria inspection, other time points can be replaced by packaging system airtightness inspection", "In commercial production, establish inspection and control measures for packaging system airtightness, pay attention to collecting and accumulating leakage and airtightness test data, which is beneficial to discover and avoid damage to packaging Sealed operational deviation". [0003] Most pharmaceutical companies use the col...

AI Technical Summary

Problems solved by technology

[0003] Most pharmaceutical companies use color water intrusion method combined with UV spectrophotometer as a routine detection method for airtightness, which has the advantages of low cost and easy operation, but at the same time has the following disadvantages: low safety

With the increasing update of detection technology and means, drug regulations advocate strict assessment and control of possible risks of drugs, and the original sensitivity cannot continue to meet the requirements

Poor anti-interference ability

The UV spectrophotometer requires that the absorption wavelengths of the drug matrix and methylene blue do not interfere with each other. Most drugs and excipients have UV absorption. If they are close to the maximum absorption wavelength of methylene blue, they will interfere with the detection.

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