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马沙骨化醇（Maxacalcitol）正在临床试验中。维生素D衍生物与皮质类固醇或光疗合并使用可以提高疗效，减少刺激的不良反应，减少光疗的剂量。适用于斑块型银屑病，每日外用2次，目前国际上通行的用法为与皮质类固醇软膏早晚交替使用。大约10-15%的患者对皮肤有刺激反应，故不宜外用脸部。
オキサロール軟膏25μg／g／オキサロールローション25μg／g
商標名
Oxarol Ointment
Oxarol Lotion
一般名
マキサカルシトール（Maxacalcitol）（JAN）
慣用名
22‐oxacalcitriol
1α, 25‐dihydroxy‐22‐oxavitamin D3
化学名
(＋)‐(5Z, 7E)‐(1S, 3R, 20S)‐20‐(3‐Hydroxy‐3‐methylbutyloxy)‐9, 10‐secopregna‐5, 7, 10(19)‐ riene‐1, 3‐diol
構造式
分子式
C26H42O4
分子量
418.61
性 状
白色の結晶性の粉末である。
メタノールに極めて溶けやすく、エタノール（99.5）に溶けやすく、ジエチルエーテルにやや溶けやすく、水にほとんど溶けない。
包装
軟膏：10g×１
軟膏：10g×10
ローション：10g×１
ローション：10g×10
製造販売元
中外製薬株式会社
原处方资料附件：http://www.kegg.jp/medicus-bin/japic_med?japic_code=00052905
As with the keratosis treatment "Oxarol® Ointment" (nonproprietary name, maxacalcitol; hereafter, "Ointment") for which marketing approval was also granted to Chugai, "Lotion" contains the active vitamin D3 derivative maxacalcitol as an active ingredient. With the modified new formulation for enhanced patient convenience, "Lotion" is easy to apply to common sites of psoriasis vulgaris including hairy areas such as head. "Lotion" containing active vitamin D3 will be a useful new topical treatment option.
1. About Maxacalcitol
Maxacalcitol, an active vitamin D3 derivative developed by Chugai, inhibits proliferation and induces differentiation of epidermal keratinocytes. Since market launch of "Ointment" containing the active ingredient maxacalcitol in October 2001, it has been widely used in patients with keratosis including psoriasis vulgaris, remarkably improving the symptoms.
2. Features of "Oxarol® Lotion"
"Lotion" is an emulsion lotion that can be easily applied to hairy areas such as head and has excellent usability. "Lotion" has shown to be highly effective and safe as with "Ointment" in the controlled clinical study in patients with psoriasis vulgaris.
Dermal transfer of "Lotion" in human skin has shown to be equivalence to that of "Ointment". "Lotion" with excellent usability and efficacy/safety comparable to "Ointment” will be a useful new topical treatment option for psoriasis vulgaris.
The most frequently observed adverse drug reactions in the clinical study were 4 events of skin irritation (4.7%), 3 events of skin exfoliation (3.5%), and 2 events each of eczema and erythema (2.3%).
Product Summary
[Product Name] Oxarol® Lotion
[Nonproprietary Name] Maxacalcitol
[Composition] One gram of Oxarol® Lotion contains maxacalcitol 25 μg.
[Indications] Psoriasis vulgaris, ichthyosis, palmoplantar keratosis
[Dosage and Administration] Appropriate amount of Oxarol® Lotion should be applied to the affected area twice daily. Depending on the symptom, application frequency should be decreased as necessary.
[Precaution concerning Dosage and Administration] The maximum recommended daily dose of maxacalcitol is 250 μg, or 10 g of topical maxacalcitol.
[Package] Bottle; 10 g x 1, 10 g x 10
[Manufacturer] Chugai Pharmaceutical Co., Ltd.
[Release Date] June 18, 2007
[Date of Approval] March 15, 2007
[Date of NHI Drug Price Listing] June 15, 2007
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