ニフェジピン製剤の品質におよぼす光の影響

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In order to investigate the influence of light on the quality of commercial nifedipine preparations, the light of fluorescent lamp (FL-1.5 SW-G, Hitachi, 860 lux) was irradiated to 3 kinds of tablets and 3 kinds of capsules at a distance of 30 cm from the beam source and then the content of nifedipine was determined every week over 4 weeks by high performance liquid chromatography under the light of infrared lamp. This irradiation was also carried out to pure and fine crystal of nifedipine in a test tube and then the light-degradation product was identified with infrared spectrophotometer.The results were as follows: 1) In the case of irradiation to the preparations with PTP package, the contents of nifedipine of all the preparations tested remained unchanged after 2 weeks, but those of preparation C(tablet) and E(capsule) decreased after 4 weekes. 2) In the case of irradiation to the preparations without PTP package, a decrease in the content of nifedipine was observed in preparations C and E after a week and in all the preparations tested after 3 weeks, although the decrease varied. 3) In the case of irradication to the pure and fine crystals, the content of nifedipine[4-(2'-nitrophenyl)-2, 6-dimethyl-3,5-dimethoxycarbonyl-1,4-dihydro-pyridine]decreased gradually with time and changed completely into 4-(2'-nitrosphenyl)-2,6-dimethyl-3,5-dimethoxycarbonyl-pyridine upon exposure to the light for 7 days.In order to investigate the influence of light on the quality of commercial nifedipine preparations, the light of fluorescent lamp (FL-1.5 SW-G, Hitachi, 860 lux) was irradiated to 3 kinds of tablets and 3 kinds of capsules at a distance of 30 cm from the beam source and then the content of nifedipine was determined every week over 4 weeks by high performance liquid chromatography under the light of infrared lamp. This irradiation was also carried out to pure and fine crystal of nifedipine in a test tube and then the light-degradation product was identified with infrared spectrophotometer. The results were as follows: 1) In the case of irradiation to the preparations with PTP package, the contents of nifedipine of all the preparations tested remained unchanged after 2 weeks, but those of preparation C (tablet) and E (capsule) decreased after 4 weeks. 2) In the case of irradiation to the preparations without PTP package, a decrease in the content of nifedipine was observed in preparations C and E after a week and in all the preparations tested after 3 weeks, although the decrease varied. 3) In the case of irradiation to the pure and fine crystals, the content of nifedipine[4-(2'-nitrophenyl)-2, 6-dimethyl-3,5-dimethoxycarbonyl-1,4-dihydro-pyridine]decreased gradually with time and changed completely into 4-(2'-nitrosphenyl)-2,6-dimethyl-3,5-dimethoxycarbonyl-pyridine upon exposure to the light for 7 days.
日本医療薬学会の論文
1984-06-20

ニフェジピン製剤の品質におよぼす光の影響

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