Usefulness of the Final Filter of the IV Infusion Set in Intravenous Administration of Drugs-Contamination of Injection Preparations by Insoluble Microparticles and Its Causes

Autor: Yoshito Nakagawa, Keiji Kuramoto, Toru Shoji
Rok vydání: 2006
Předmět:
Zdroj: YAKUGAKU ZASSHI. 126:289-295
ISSN: 1347-5231
0031-6903
DOI: 10.1248/yakushi.126.289
Popis: The purpose of this study is to clarify the presence of so much insoluble microparticles in the injections and to con- ˆrm the usefulness of thenallter for its removal. The test drugs used were Doyle1 g vial, Cefotax1 g vial, Minomy- cin100 mg vial, Omegacin0.3 g vial, Maxipime1 g vial, Rocephin1 g vial, Isovorin25 mg vial, Diamox500 mg vial and Fungizone50 mg vial. 1) An appropriate volume of physiological saline was poured into the test drug vial from the 500 ml physiological saline bag. 2) The dissolution of the preparation was checked. 3) That test drug solution was returned into the same 500 ml physiological saline bag. 4) 5 ml of test drug solution was extracted from the inside of the 500 ml physiological saline bag. 5) The number of insoluble microparticles in the each test drug solution at pre- and post-ˆltrations were counted by using a particle counter for the solution. Two results were shown as follows (microparti- cle size: 5 m mo r greater), (a) Doyle 1g (ASPC): The number of insoluble microparticles in pre- and post-ˆltrations of aD oyle1 g vial were 250± 45 and 0/5 ml, respectively (microparticle size:≦5 mm 1662/ 5m l, 5~10 mm: 238/ 5m l,> 10 mm: 11/ 5m l). (b) Diamox500 mg (acetazolamide): The number of insoluble microparticles in pre- and post-ˆltra- tions of Diamoxwere 158± 53 and 0.3± 0.47/5 ml, respectively (microparticle size:≦5 mm 4030/ 5m l, 5―10 mm: 144/ 5m l,>10 mm: 14/ 5m l). The presence of great numbers of insoluble microparticles in several injection prepara- tions was claried. Although the all test drugs used cleared the criteria of the number of insoluble microparticles of the Japanese Pharmacopoeia, it was suggested to be not suitable that great numbers of insoluble microparticles were ad- ministrated in the body ‰uid of patients, because a possibility to occlude capillaries and/or to injure the tissues by them was been thought. But we could remove them nearly completely by passing the solutions of drugs through an infusion ˆlter. Otherwise, in this examination, we found that so much insoluble microparticles derived from the disposable syringe (10 ml) were used for dissolving freeze-dried preparations routinely (microparticle size:≦5 mm 329/ 5m l, 5―10 mm: 125/ 5m l,>10 mm: 39/ 5m l). These results suggest that incorporation of anallter in the IV line is extremely necessary not only for the prevention of bacterial infections, but also for elimination of insoluble microparticles. Key words―microparticles; removal; filter; freeze-dried preparation; contamination
Databáze: OpenAIRE
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