Quality Testing for Kallidinogenase Preparations by HPLC-post-column Analysis

In the present study, according to the standardized methods, we tried to evaluate the quality and efficacy of oral kallidinogenase preparations, which were manufactured under the new quality standard, and the stabillity and purity tests by using HPLC-post-column analysis.Results obtained by the stan...

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Bibliographic Details
Published inJapanese Journal of Hospital Pharmacy Vol. 16; no. 2; pp. 86 - 93
Main Authors MINAKUCHI, KAZUO, KUJIME, TOSHIHIDE, UMEDA, TAKABUMI, FUSHITANI, SHUJI, YOSHISAKA, TAKAICHI, TAKASUGI, MASUMITSU
Format Journal Article
LanguageJapanese
Published Japanese Society of Pharmaceutical Health Care and Sciences 1990
Subjects
HPLC-post-column analysis
kallidinogenase
kallidinogenase preparations
purity test
quality test
stability test
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Summary:In the present study, according to the standardized methods, we tried to evaluate the quality and efficacy of oral kallidinogenase preparations, which were manufactured under the new quality standard, and the stabillity and purity tests by using HPLC-post-column analysis.Results obtained by the standardized methods showed that all of the specimens were in compliance with standards.The purity test by HPLC-post-column analysis revealed that many specimens were found to have enzyme activities other than kallidinogenase.The stability test showed that most specimens were stable enough under the storage conditions at 50°C for 2 months, but one particular specimen reduced to 30% of the labeled activity under the same conditions.These results suggest that although the products have been manufactured and marketed under the standardized criteria, the qualities of kallidinogenase preparations are found considerably different among manufactures.
ISSN:0389-9098
2185-9477
DOI:10.5649/jjphcs1975.16.86