Method for detecting bacterial endotoxin in nalbuphine hydrochloride bulk drug

Abstract

The invention belongs to the technical field of microbiological examination, and particularly relates to a method for detecting bacterial endotoxin in a nalbuphine hydrochloride bulk drug. The methodcomprises the following steps: (1), determining a bacterial endotoxin limit value L: limiting the bacterial endotoxin in an injection to consider later clinical medication safety, and determining thebacterial endotoxin limit value L to be equal to 2EU / mg; (2), rechecking the sensitivity of the tachypleus amebocyte lysate: rechecking the sensitivity of the tachypleus amebocyte lysate by using bacterial endotoxin standard substances with the concentrations of 2 lambda, lambda, 0.5 lambda and 0.25 lambda, and recording a result; (3), performing interference test pre-experiment: determining the maximum effective dilution ratio to be 80 times; (4), carrying out interference test of the test sample: determining the non-interference dilution ratio to be 160 times; and (5), detecting the contentof bacterial endotoxin in the test sample: taking the test sample to prepare a stock solution with the concentration of 10mg / ml, gradually diluting to 160 times to obtain a diluent, diluting the diluent by 1 time, 2 times, 4 times and 8 times to obtain a test sample solution, respectively reacting the test sample solution with the tachypleus amebocyte lysate, and quantifying the content of endotoxin in the test sample by determining the reaction concentration.

Description

technical field [0001] The invention belongs to the technical field of microbiological testing, and in particular relates to a detection method for bacterial endotoxin in nalbuphine hydrochloride bulk medicine. Background technique [0002] Nalbuphine hydrochloride belongs to agonist-antagonist morphine drugs, which is used to relieve moderate to severe pain, and can also be used as an adjuvant drug during compound anesthesia. analgesia. [0003] In the development of injection products, in order to ensure that patients will not cause adverse reactions such as fever after injection of drugs, it is necessary to strictly control the bacterial endotoxin content in raw materials to ensure product safety. Bacterial endotoxins, a component of the cell walls of many Gram-negative bacteria called lipopolysaccharides, are the major constituents of pyrogens. A large amount of bacterial endotoxins entering the blood will trigger a thermal reaction, leading to fever, leukocyte reactio...

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Problems solved by technology

[0004] Common detection methods for bacterial endotoxin are rabbit pyrogen method and Limulus reagent method. The rabbit pyrogen method is cumbersome and time-consuming to operate, and cannot be used for quality monitoring in the production process. The gel limit test has low requirements on experimental equipment. The method can only analyze whether the content of endotoxin in the product exceeds the standard, but cannot obtain exact quantitative results

[0005] At present, there is no literature or patent report on the method for bacterial endotoxin detection of nalbuphine hydrochloride raw material drug

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