造福台灣腰椎管狹窄症患者！小野攜手中化引進新藥 資料提供：MoneyDJ理財網 作者：鉅亨網新聞中心綜合報導 發表日期：20150317 MoneyDJ新聞 2015-03-17 記者 蔡承啟 報導 日本知名新藥研發公司小野藥品(Ono)16日發布新聞稿宣布，已和台灣中化(1701)就小野所擁有的前列腺素E1類似物的口服製劑「limaprost alfadex(以下簡稱limaprost、日本稱為Opalmon)」於台灣的研發/銷售一事締結了契約，而根據契約內容，小野將limaprost於台灣市場的獨家研發/銷售權授予中化，而中化在研發並取得藥證後，將可在台灣販售limaprost，且中化並將依limaprost銷售額支付特許費(loyalty)給小野。小野指出，limaprost是一種可用來治療「腰椎管狹窄症」所造成的下肢疼痛和麻木感等主觀症狀的口服前列腺素E1類似物製劑，而目前在台灣針對腰椎管狹窄症患者尚未出現具體有效的治療藥，因此期望藉由此次和中化的合作，對台灣腰椎管狹窄症患者帶來新的治療契機。 limaprost可透過擴張周邊血管及抑制血小板凝集的作用，以達到促進血液循環的效果。Limaprost於1988年在日本首先被核准用於治療血栓閉塞性血管炎之缺血症狀，如皮膚潰瘍、疼痛、冷感等；爾後又於2001年增加了後天性「腰椎管狹窄症」的適應症，可治療其造成的下肢的疼痛和麻木感等主觀症狀，以及行走不便。 根據嘉實XQ全球贏家系統報價，小野16日收盤跌1.09%至13,640日圓，今年迄今漲幅高達27.12%；中化16日收盤跌0.73%至20.35元，今年迄今跌幅為0.25%。
Chem Pharm Bull (Tokyo). 2008 Jan;56(1):7-11.
Improved stability of Opalmon tablets under humid conditions IV: effect of polysaccharides and disintegrants on the stability and dissolution property of Opalmon tablets. Pharmaceutical Development Laboratories, Ono Pharmaceutical Co., Ltd., We studied the effects of dextran, dextrin, and disintegrants on the chemical stability of Opalmon tablets containing Limaprost-alfadex (Limaprost/alpha-cyclodextrin complex) and found that the addition of dextran or dextrin significantly improved the chemical stability of Opalmon tablets under high humidity, compared to lactose. We also examined how dextran stabilizes Limaprost in Opalmon tablets and studied the formulation of Opalmon tablets in order to achieve higher chemical stability, rapid dissolution and reduced stickiness. The results suggested that dextran increases stabilization after moisture adsorption by decreasing the dissociation of Limaprost-alfadex to the free drug and alpha-cyclodextrin in the dextran matrix, when compared with the lactose matrix. The stickiness of Opalmon tablets containing dextran and dextrin was negligible when dextran and dextrin amounted to less than 20% of the formulation. By selecting a proper disintegrant, we obtained Opalmon tablets with higher chemical stability and rapid dissolution properties.
Effect of oral administration of prostaglandin E1 on erectile dysfunction
Br J Urol. 1997 Nov;80(5):772-5. OBJECTIVES: To investigate the effect of limaprost, an oral prostaglandin E1 (PGE1) derivative, on erectile dysfunction and to compare the effects of limaprost with a Chinese herbal drug, gosyajinki-gan. PATIENTS AND METHODS: The study comprised 50 consecutive patients with mild erectile dysfunction who showed a good erectile response to intracavernosal injection with 20 micrograms of PGE1. Limaprost was administered to the first 25 patients (30 micrograms three times daily) and gosyajinki-gan (7.5 g three times daily) to the next 25 patients, for 8 consecutive weeks. Patients were evaluated by their ability to achieve vaginal penetration and by a subjective assessment of erectile function (penile rigidity and maintenance of erection) before and after the treatment, using a self-administered questionnaire. Objective measurements (nocturnal penile tumescence, NPT, values) were also evaluated. RESULTS: Eleven of the 24 patients who received limaprost without interruption and four of the 24 taking gosyajinki-gan succeeded in vaginal penetration; the difference in the positive response rate was significant. The mean increment of NPT was significantly higher with limaprost treatment. However, all positive responders in both groups did not experience a full erection. There were no side-effects in any patient except one in the limaprost group who developed a facial flush. Thus the treatment was mild enough to be tolerated. CONCLUSION: Limaprost was more effective for mild erectile dysfunction than was gosyajinki-gan.
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