コレステロール負荷食ウサギの脂質異常に対するPravastatin先発医薬品と後発医薬品の効果

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Mevalotin^[○!R] containing pravastatin, a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, is the brand medicine and well known to be effective for patients with dyslipidemia. Now, more than 20 generic pravastatins are available for clinical therapy. We compared pharmaceutical property of Mevan^[○!R], a generic pravastatin, with that of Mevalotin^[○!R]. According to the definition of the Japanese Pharmacopoeia, Mevalotin^[○!R] 10mg tablets were uniform in pravastatin content, whereas 5mg tablets were rather variable. Variation in pravastatin content of Mevan 5mg tablets was the same as Mevalotin^[○!R] 5mg, whereas that of 10mg tablets was very variable. The plasma concentration of pravastatin in the normal rabbits continuously increased until 180min after oral administration of 30mg Mevan^[○!R], whereas it increased in a biphasic pattern after 30mg Mevalotin^[○!R]. All rabbits were fed 0.2% cholesterol diet throughout the experiment. After 8 weeks, oral administration of either Mevalotin^[○!R] or Mevan^[○!R] was started at the dose of 30mg pravastatin/day for 16 weeks. After a transient increase for a few weeks, the plasma levels of total- and LDL-cholesterol gradually decreased in Mevalotin^[○!R] group, whereas these levels did not significantly changed in Mevan^[○!R] group within 16 weeks. The level of HDL-cholesterol in Mevan^[○!R] group tended to increase but not in Mevalotin^[○!R] group. The triglyceride level in Mevan^[○!R] group changed as well as that in Mevalotin^[○!R] group until 10 weeks after administration, and then gradually increased. The present results suggest that pharmaceutical properties of Mevan^[○!R] are not always identical with those of Mevalotin^[○!R].
社団法人日本薬学会の論文
2009-01-01

コレステロール負荷食ウサギの脂質異常に対するPravastatin先発医薬品と後発医薬品の効果

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