部份中文伊班膦酸钠处方资料（仅供参考）
商标名：Bonviva
英文名：Ibandronate Sodium Hydrate
中文名：伊班膦酸钠
生产商：中外制药
药品简介
Boniva(ibandronate sodium，伊班膦酸钠)是首个和迄今唯一用于绝经后妇女骨质疏松症的一月1次药品。 
药效分类
骨质疏松症药物
批准日期：2013年8月
商標名
Bonviva
一般名
イバンドロン酸ナトリウム水和物
（Ibandronate Sodium Hydrate）（JAN）
化学名
Monosodium
［1-hydroxy-3-（methylpentylamino）propane-1,1-diyl］diphosphonate monohydrate
構造式
分子式
C9H22NNaO7P2・H2O
分子量
359.23
性　状
白色—黄白色粉末。它容易融于水中，几乎不溶于甲醇、乙醇和二甲基甲酰胺。融分
开始在171圈附近熔化，在198级附近分解。
处理上的注意
由于在严酷的考试(光)中仅认定了类似性物质的增加，所以打开外箱后要避免光的保存。
药效药理
1.药理作用
(1)骨吸收抑制作用
在兔子破骨细胞培养系统中，破骨细胞减少形成象牙碎片的吸收凹陷(in vitro)。
(2)在骨质疏松症模特动物上的作用
1)在老鼠卵巢摘除模式中，12个月来连续进行皮肤下注射时，容量依赖抑制了骨密度及骨强度的下降。而且在有12个月间歇性皮肤(25日1次)时，抑制了骨密度及骨强度的下降。
2).在食蟹猴卵巢摘除模式中，连续16个月间歇(30日一次)进行静脉内注射时，抑制骨密度及骨强度的下降，并且验证了骨密度和骨强度的正比。另外，还抑制了血清、尿液中的代谢类固醇(血清骨骼型碱性肾上腺素、血清素尿中i型胶原蛋白架桥n端字幕组、尿中脱氧胞苷)的上升。
(3)骨石灰化的影响
1)在成长期白鼠中，连续7天进行皮肤下发，4780μg/kg(1000μgp /kg注6):量的增加作用容量的容量达到4780μg/kg(1000μgp /kg注6):没有承认骨石灰化过程的障碍。
2)纯卵巢子宫摘除模式中，100μg/kg(约为表示抑制骨量作用的容量的100倍)为限，没有承认类骨宽度增加和钙化速度下降。
3)关于食蟹猴卵巢摘除模式，在30μg/kg(伊带隆酸容量:16个月间歇性(30日1次)静脉内注射)中，没有允许增加类骨宽度。
注6)分子内包含的基于磷原子的重量的重量表示
注7)4780μg/kg的容量中，胫骨骨干末端的成长板直下，被认为是基于抑制添加骨基质的低石灰化领域得到了认可。
注8)与输入前的值的比较
(4)对骨折修复的影响
对骨髓除去及骨缺损孔形成制狗骨折模型，在36周内连续用1μg/kg的容量作为伊带罗恩酸时，骨髓除去大腿皮质骨中的骨头单位数和胫骨缺损孔中形成的假骨没有受到影响。
2.作用机制
异丙酸对骨髓基质的氢氧磷酸具有很高的亲和性，在注射后会分布到骨头。这可以被认为是通过抑制进入破骨细胞后的法拉利实磷酸合成酶，由此抑制破骨细胞的功能，从而显示出抑制骨吸收的作用。
适应症
骨质疏松症
用法与用量
通常，成人每个月服用1毫克月静脉内注射类固醇类药物。
临床成绩
60岁以上的原发性骨质疏松症患者为对象的随机化二重盲検群间比较试験(被験药群,本剂0.5 mg注4)以及本剂1毫克)中,3年的非创伤性椎体骨折发生频率的生命表法的推测值(95%信赖区间),本剂1 mg群(イバンドロン酸作为1个月1次1 mg,静脉内注射381例,其中男性28例)及对照组(リセドロン连日来作为酸钠2.5 mg,口服,375例中男性32例),分别为16.07%及17.58% (12.19 ~ 19.94%)(13.55 ~ 21.62%)。通过非外伤椎体骨折发生频率的层别cox回归分析，本产品1mg群的松弛比(90%信任区间)为0.88(0.65 ~ 1.20)，证明了该药对该药的不劣性(非劣性限界值1.55)。
3年后的腰椎骨质密度变化率的平均值(95%信赖区间),本剂1 mg群9.02%(8.32 ~ 9.72%)及对照组7.61%(6.92 ~ 8.30%),3年后的股骨近位部骨密度变化率的平均值(95%信赖区间),本剂1 mg群3.09%(2.68 ~ 3.51%)及对照组(1.58 ~ 2.45%)的2.02%。
包装
10mg: 1ml×1缸，1ml×10缸
制造商
中外制药公司
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明附件：http://www.info.pmda.go.jp/go/pack/3999438G1027_1_04/ .

http://www.kegg.jp/medicus-bin/japic_med?japic_code=00061939
Bonviva
Active Substance: ibandronic acid
Common Name: ibandronic acid
ATC Code: M05BA06
Marketing Authorisation Holder: Roche Registration Ltd.
Active Substance: ibandronic acid
Status: Authorised
Authorisation Date: 2004-02-23
Therapeutic Area: Osteoporosis, Postmenopausal
Pharmacotherapeutic Group: Drugs for treatment of bone diseases
Therapeutic Indication
Treatment of osteoporosis in postmenopausal women at increased risk of fracture.
A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
What is Bonviva?
Bonviva is a medicine that contains the active substance ibandronic acid. It is available as tablets (150 mg) and as a solution for injection in a prefilled syringe (3 mg).
What is Bonviva used for?
Bonviva is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks). Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.
The medicine can only be obtained with a prescription.
How is Bonviva used?
Bonviva can be given either as a tablet or as an injection into a vein. If the tablet is used, the dose is one tablet every month, preferably on the same date each month. The tablet must always be taken after an overnight fast, one hour before any food or drink except for water, and with a full glass of plain water. (In areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used.) The patient must not lie down for one hour after taking the tablet. The dose by injection is 3 mg once every three months. Patients taking Bonviva should also take vitamin D and calcium supplements if they do not get enough from their diet.
How does Bonviva work?
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
The active substance in Bonviva, ibandronic acid, is a bisphosphonate. It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. Blocking the action of these cells leads to less bone loss.
How has Bonviva been studied?
Bonviva has been studied in three main studies involving women with osteoporosis. The first study compared Bonviva 2.5-mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years. The other two studies compared the 150-mg monthly tablets (1,609 patients) and the injections (1,395 patients) with the 2.5-mg once-daily tablets. The studies looked at the change in the density of the bones in the spine and the hip over two years.
The 2.5-mg once-daily tablets used in the studies are no longer authorised.
What benefit has Bonviva shown during the studies?
In the first study, daily treatment with Bonviva 2.5-mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo. The other two studies showed that the 150-mg monthly tablets and the injections were more effective than the 2.5-mg once-daily tablets at increasing bone density in the spine and the hip. Over two years, bone density in the spine increased by 7% with the monthly tablets and by 6% with the injections, compared with 5% with the daily tablets. In the hip, bone density increased by 4% with the monthly tablets and by 3% with the injections, compared with 2% with the daily tablets.
What is the risk associated with Bonviva?
The most common side effects with Bonviva (seen in between 1 and 10 patients in 100) are arthralgia (joint pain) and influenza (flu)-like symptoms. For the full list of all side effects reported with Bonviva, see the package leaflet.
Bonviva must not be used in people who are hypersensitive (allergic) to ibandronic acid or any of the other ingredients. It must not be used in patients who have hypocalcaemia (low blood calcium levels). The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit upright for at least an hour.
Why has Bonviva been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Bonviva’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Other information about Bonviva
The European Commission granted a marketing authorisation valid throughout the European Union for Bonviva on 23 February 2004.