著者

平川 雅章 立石 真理 牧野 和隆 千堂 年昭 伊藤 善規 大石 了三

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.29, no.1, pp.20-27, 2003-02-10 (Released:2011-03-04)

参考文献数

10

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Although the standards for the quality of rubber closures on injectable glass vials were specified in USP 24 in the U.S. and BP 2001 in the U.K., no such guidelines for quality control exist in Japan. In the present study, we investigated the quality of rubber closures on glass vials of frequently-used anti-biotic and anti-viral injections in our hospital, according to the quality control method of rubber closures for aqueous infusion that was standardized in JP14. Sufficiently washed rubber closures were immersed in distilled water, and test solutions were prepared after gently shaking them for 5 min or heating them at 121°C under high-pressure steam for 60 min. The optic transmittance in the resultant solutions was measured at 430nm and 650nm, and the findings were compared with those for the standard values in JP14 for rubber closures on aqueous infusions. Of 23 different rubber closures tested, only one showed a lower transmittance at 430nm when the solution was prepared by gentle shaking. Under the condition of heating with high-pressure steam, 15 products did not reach the criteria at both wavelengths, 3 did not meet the standards set at either of the wavelengths, but 5 had no qualitative problems. We also checked the materials stuffed in 0. 45μm membranes after filtration with an injection by microscopic observations using scanning electron microscopy and by an element analysis with an X-ray energy dispersive microanalyzer. A number of micro-particles were observed and they were found to be composed of silicon, aluminium and titanium.These results indicate that the quality of rubber closures of injectable glass vials varies among products. Therefore, the standards and guidelines for the quality control of rubber closures of injectable glass vials should be established in JP.

著者

吉田 実 平川 雅章 堤 千秋 立石 真理 中島 和博 岡部 昌之 末安 正典 吉川 学 中尾 泰史 伊藤 善規 大石 了三

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.29, no.2, pp.189-195, 2003-04-10 (Released:2011-03-04)

参考文献数

11

被引用文献数

1 1

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We examined the procedures for dispensing tablets or capsules that are not approved for crushing after checking the basis for such non-approval regarding 108 medicines introduced in our hospital. The problems are summarized as 1) a reduction in the pharmacological efficacy, 2) lowering the compliance due to a bitter taste or unpleasant odor, 3) dispersing hazardous powder, and 4) a disappearance of the efficacy of improved formulation such as for enteric coating.The taste of the ground tablets or capsules that are indicated to not be crushed was examined and compared with various concentrations of quinine hydrochloride powder in 8 healthy volunteers who showed a normal response to a bitter taste. Thirty-one out of 43 drugs were found to be tolerable to the taste, in which 13 drugs were less bitter than 0.5% quinine hydrochloride powder. However the other drugs either induced numbness or had a pungent taste and unpleasant odor, which were also considered to become the major reasons for nonapproval for crushing. Therefore, we found that several tablets have no serious problems, when they are dispensed after grinding. On the other hand, a number of hygroscopic medicines and anticancer agents tended to easily disintegrate in water. As a result, they can be prescribed by suspending them in water immediately before taking them. Our findings suggest that several tablets or capsules that are non-approved for crushing may thus be dispensed without any serious problems after crushing or disintegrating them in water. Therefore, our present findings may offer some useful information on the countermeasures for dispensing tablets and capsules that are not approved for crushing.