Astellas和小野公司的口服二膦酸盐Bonoteo／Recalbon（minodronate）已在日本获批准用于治疗骨质疏松。对于每日服用一次的该药来说，此次批准在全球尚属首次。当地的Ⅲ期临床试验显示，与安慰剂相比，该药在脊柱骨折发生率方面有显著获益。同时公司还强调了1mg本品在肠胃副作用方面有很大的减少和高度有效
本品用于骨质疏松症的治疗，通过抑制破骨细胞内焦磷酸法呢酯(FPP)合成酶活性，抑制破骨细胞的骨吸收，降低骨转换，起到防治骨质疏松的效果。是1mg的片剂， 1天1次，1次1片。该药品的比较优势表现在：与目前临床上常用的双膦酸盐比较，其抑制骨吸收的活性强，是英卡膦酸二钠的2倍，阿仑膦酸的钠的10倍，帕米膦酸二钠的100倍，且消化道不良反应发生率较现有的双膦酸类药物少。

通用名：米诺膦酸

英文名： minodronic acid

汉语拼音： Minuolinsuan

结构式为：

分子式： C 9 H 12 N 2 O 7 P 2

分子量： 322.16

理化性质：本品为白色 - 微红白色的结晶或结晶性粉末。本品极难溶于水，基本不溶于乙醇（ 99.5 ）。本品可溶于氢氧化钠试验溶液。

（2）药品的药理作用及作用机制：

药理作用：

米诺膦酸是一种含氮的 二碳磷酸盐化合物，可用于治疗骨质疏松症。

作用机制：

米诺膦酸通过抑制破骨细胞内的焦磷酸法尼酯合成酶，抑制破骨细胞的骨吸收功能，进而使骨代谢循环减退。

（3）临床适应症及用法用量：

适应症 ：骨质疏松症。

用法用量： 口服，每日一次，每次 1mg ，服药后至少 30 分钟内不可横卧，至少 30 分钟以内避免摄取水以外的食品饮料。

品牌名称：

小野：RECALBON ®片1毫克
安斯泰来：Bonoteo ®片1毫克

通用名称：minodronic酸水合物

主治：骨质疏松症

用法用量：
通常在成年人中，有1 minodronic酸水合物毫克采取足够量的水（180毫升）（或温水），每天口服一次一起在觉醒的时候。必须采取这种药物不说谎至少在30分钟前，第一食品，饮料（除白开水除外），和其他口服药物了。

鲜明的特点：
1。 Minodronic酸水合物是，首先在日本发现的双膦酸盐。
2。这也是第一次双磷酸盐，示范效果显着的预防骨骨折优于日本骨质疏松症患者服用安慰剂。
3。它显示了在骨矿物密度（BMD）的增量良好的效果。
4。它也具有强大的减少骨吸收标志物的从与药物治疗的开始。
5。它表现出极为骨吸收（在体外和大鼠）强大的抑制作用。
6。这种药物是（。直径6.6毫米，3.0毫米厚）在一个易于给药包衣片的小电影
7。作者：（副作用）的不良反应发生率观察18.6％（206例患者1,108），包括测试值异常，而那些包括胃部和腹部不适35例（3.2％），27例（2.4％）腹部疼痛在血液中22例（2.0％）和15例（1.4％）胃炎钙水平下降。在上消化道疾病，如十二指肠溃疡和胃溃疡的报道为具有临床意义的不良反应。
包装：
RECALBON ®片1毫克：100片（吸塑包装和瓶）
Bonoteo ®片1毫克：100片（吸塑包装）和500片（瓶）

* 140片（14T × 10）和700片吸塑包装（14T × 50）

-------------------------------------------------
RECALBON(リカルボン)1毫克/片 100片/瓶

米诺膦酸片
RECALBON　
リカルボン錠50mg
有效成分：米诺膦酸    二膦酸盐   Minodronic Acid Hydrate
生产厂家：小野药品
适合病症：骨质疏松症
药品形状：片剂
有效成分量：50mg /片
生产厂家：小野藥品工業株式會社

PRODUCT SUMMARY:
Brand name:  
Ono: 
RECALBON® Tablets 1mg
Astellas:  

Bonoteo® Tablets 1mg
 
Generic name: 

minodronic acid hydrate
 
Indication:

Osteoporosis
 
Dosage and administration:
Normally in adults, 1 mg of minodronic acid hydrate is taken orally together with enough amount of water (180 mL) (or lukewarm water) once a day at the time of awakening. The drug must be taken without lying down at least for 30 minutes before the first food, beverage (other than plain water), and other oral medication.
 
Distinctive features:
1. Minodronic acid hydrate is a bisphosphonate that was first discovered in Japan.
2.   It is also the first bisphosphonate that demonstrated significant effect in prevention of bone fractures superior to placebo in Japanese osteoporosis patients.
3.   It shows an excellent effect in increment of bone mineral density (BMD).
4.   It also exhibits potent reduction of a bone resorption marker from the beginning of the treatment with the drug.
5.   It exhibits extremely potent inhibition of bone resorption (in vitro and in rats).
6.   The drug is in an easy-to-administrated small film coated tablet (6.6 mm in diameter, 3.0 mm thick.)
7.   Incidence of adverse reactions (side effects) was observed in 18.6% (206 out of 1,108 patients) including abnormal laboratory test values, and those include stomach and abdominal discomfort in 35 patients (3.2%), abdominal pain in 27 patients (2.4%), decrease in blood calcium level in 22 patients (2.0%), and gastritis in 15 patients (1.4%). Disorders in upper gastrointestinal tract such as duodenal ulcer and gastric ulcer were reported as clinically significant adverse reactions.
 
Packaging:             
RECALBON® Tablets 1mg: 100 tablets (blister packaging and bottle)
Bonoteo® Tablets 1mg: 100 tablets (blister packaging) and 500 tablets (bottle)
 
NHI reimbursement prices: 135.50 yen / 1 mg tablet
 
Date of NHI price listed: March 13, 2009
 
Date of launch:       

April 7, 2009
 
* 140 tablets (14T×10) and 700 tablets (14T×50) in blister packaging will be available around June.
 
Japan, April 6, 2009 - Ono Pharmaceutical Co., Ltd. (“Ono”; headquarters: Osaka; President and Representative Director: Gyo Sagara) and Astellas Pharma Inc. (“Astellas”; headquarters: Tokyo; President and CEO: Masafumi Nogimori) today announced that RECALBON® Tablets 1mg (Ono) / Bonoteo® Tablets 1mg (Astellas) (generic name: minodronic acid hydrate) will be launched on April 7, 2009 in Japan. The drug has been jointly developed by the two companies and was granted a Japanese marketing approval for the treatment of osteoporosis on January 21, 2009.
 
Osteoporosis is a systemic bone disease characterized by decreased bone strength leading to an increased risk of bone fractures.  It is estimated that over 10 million people, including potential patients, are suffering from the condition in Japan but that the number of patients continues to increase as aging population grows.  Elderly osteoporosis patients in particular are liable to vertebral or femoral neck fracture keeping some of them in bed, and therefore measures to tackle the disease by not only therapeutic but social means have been an important issue.
 
Minodronic acid hydrate is an orally taken bisphosphonate that was first discovered in Japan and exhibits extremely potent inhibition of bone resorption* in the class. It is the first drug that demonstrated significant effect in prevention of bone fractures superior to placebo in Japanese osteoporosis patients in Phase III double blind comparative study.
 
It is expected that the drug, once launched, can contribute to the improvement of the patients’ quality of life by offering an additional therapeutic option for the treatment of osteoporosis.
 
The drug will be available under the brand name of RECALBON® Tablets 1mg by Ono and Bonoteo® Tablets 1mg by Astellas respectively.
*Bone resorption: The process by which osteoclasts break down old bone losing elasticity and hardness.