院内製剤4-Aminopyridineカプセルの調製と臨床応用

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4-Aminopyridine (4-AP) capsules were prepared as a hospital preparation and clinically administered to patients with multiple screlosis (MS) after obtaining the approval of the ethical committee of our university and the informed consent of the patients. 4-AP in the trituration was extracted with methanol and quantified at 262 nm using absorption spectroscopy. 4-AP triruration was used to fill the capsules using a Semi Automatic Capsule Filling Machine. Quality tests of the preparation, weight variation tests and content uniformity tests, were then performed according to the Japanese Pharmacopoeia XIII. At first, trituration was prepared from well-ground 4-AP crystal. However, the capsules prepared from this trituration were unsuitable for the quality tests. Accordingly, 4-AP was dissolved in a small amount of water and pigment. After lactose or corn starch was gradually added as a diluent, the triturations were then dried at 60℃. The residual percentage of 4-AP in lactose heated for 4 hours was 54.1% and was lower than that in starch, 69.5%. But the percentage improved to 99.4% after drying the trituration at room temperature for 24 hours in a desiccator. The capsules prepared with this trituration were suited for the tests (5 mg of 4-AP per one capsule). Moreover, the residual 4-AP percentage in these capsules after 6 weeks was 98.0%. These 4-AP capsules were given to the patients (3-9 capsules/day p.o. in 3 divined doses). Though 4-AP itself irritates the mucous membrance, no mouth and/or esophageal irritation was observed using these capsules. The patients' quality of life all improved because both muscle weakness and impaired vision were relieved by this treatment. 4-AP capsules are thus considered to be another valuable medicative option for MS.
日本医療薬学会の論文
2000-06-10

院内製剤4-Aminopyridineカプセルの調製と臨床応用

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