Evaluate
EVALUATION-
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Mr Guo13810071004
Mr Feng13801186597 -
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Evaluation of Amoxicillin Capsule Consistency
time：2020-03-03 
browse：1385second
一. Basic information
Common name: Amoxicillin capsule
Chemical name: (2S, 5R, 6R) -3,3-dimethyl-6-[(R)-(-)-2-amino-2- (4-hydroxyphenyl) acetylamino] -7-oxygen Substituted-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate.
Pinyin name: AMOXILIN
English name: AMOXICILLIN
CAS: No. 26787-78-0
Molecular formula: C16H19N3O5S3H2O
Molecular weight: 419.46
二. Drug indications
Amoxicillin is a semi-synthetic broad-spectrum penicillin drug. Its antibacterial spectrum and antibacterial activity are basically the same as those of ampicillin, but its acid resistance is stronger than that of ampicillin, and its bactericidal effect is stronger and faster than the latter. . The half-life is approximately 61.3 minutes. Amoxicillin is stable under acidic conditions, and the gastrointestinal absorption rate is 90%, which is more rapid and complete than ampicillin. The effect is similar except that the effect on shigella is worse than that of ampicillin.
三. Relevant information of marketed preparations
1. Domestic listing
Amoxicillin capsules in China have more than 200 symbols, there are three specifications of 0.125g, 0.25g and 0.5g.
Import 4 symbols, all of which are Hong Kong companies.
2. foreign listing
Amoxicillin was launched in the UK in 1972 and was developed by Beecham Pharmaceuticals (part of GSK)
US listed in 1974, applicant GLAXOSMITHKLINE
First listed in Japan in 1975
Ebara Research is GSK
3.Selection of reference preparation
The relevant preparations of EBARA research manufacturer in FDA have been delisted.
The reference preparation is recommended to choose TEVA's 250mg amoxicillin capsules for filing applications, and apply for import after approval.