http://rdf.ncbi.nlm.nih.gov/pubchem/patent/CN-111721936-A

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filingDate 2020-06-24-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_9e8179f08a0be712b51ed1be0e797ff1
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publicationDate 2020-09-29-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-111721936-A
titleOfInvention A kind of detection method of bacterial endotoxin in nalbuphine hydrochloride crude drug
abstract The invention belongs to the technical field of microbial testing, and in particular relates to a method for detecting bacterial endotoxin in a nalbuphine hydrochloride bulk drug. The steps are as follows: (1) determining the bacterial endotoxin limit L: the bacterial endotoxin in the injection is limited to Considering the safety of later clinical use, the bacterial endotoxin limit was determined as L=2EU/mg; (2) To check the sensitivity of Limulus Reagent: the bacterial endotoxin standard with concentrations of 2λ, λ, 0.5λ and 0.25λ was used Check the sensitivity of the Limulus reagent and record the results; (3) Pre-experiment of the interference test, determine that the maximum effective dilution factor is 80 times; (4) The interference test of the test substance, determine that the non-interference dilution factor is 160 times; (5) Detect the supply The content of bacterial endotoxin in the test product: take the test product and prepare a 10 mg/ml stock solution, gradually dilute it to 160 times to obtain a dilution, and then dilute the dilution by 1, 2, 4, and 8 times to obtain The test solution is respectively reacted with the Limulus reagent, and the content of endotoxin in the test is quantified by determining the reaction concentration.
priorityDate 2020-03-04-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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Total number of triples: 25.