| 简介：
部份中文布南色林处方资料（仅供参考）
商品名：LONASEN
英文名：Blonanserin
中文名：布南色林
剂 型：2%散剂、片
生产商：
ロナセン錠2mg/ロナセン錠4mg/ロナセン錠8mg/ロナセン散2％
药用类别名称
抗 精神病药物
批准日期：2008年4月
商標名
LONASEN
一般名
ブロナンセリン Blonanserin
化学名
2-(4-Ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine
構造式
分子式
C23H30FN3
分子量
367.50
性状：
白色结晶性粉末。 易溶于醋酸(100), 不溶于甲醇或乙醇(99.5), 不易溶于水。
熔点
123 ~ 126°c
药用药理学
1. 药理作用
在动物实验中, 观察到以下药理作用。
2. 作用机制
体外受体结合试验中, 溴西林对多巴胺D2受体亚科(D2, D3)和血清素5-HT2A受体有亲和力。虽然主要代谢物n-甲替太酸对多巴胺D2受体亚科(D2, D3)和血清素5-HT2A受体有亲和力, 但多巴胺D2受体的亲和力约为溴西林的一半。此外, 还观察到血清素5-HT2C 受体和5-HT6受体的n-去甲酯亲和力。然而, 溴精和n-脱甲基丁酯、肾上腺素α-1、组胺H1、对麝香素M1等受体的亲和力较低。
适应症
精神分裂症
用法与用量
通常情况下, 成人 1次4毫克作为布洛努林, 开始每天两次餐后口服给药, 逐渐增加。 餐后口服, 按第8天至16毫克的两倍作为维持量。
需要注意的是, 根据年龄和症状, 每日剂量不超过24毫克。
临床结果
利培定和氟哌啶醇作为对照药物进行双盲比较试验。该剂(8~24mg)或对照剂(利培酮2~ 6毫克或氟哌啶醇4~12mg) 在早餐后和晚餐后每天服用两次。最终评价时的阳性和阴性症状评价量表 (阳性和阴性综合征量表; PANSS) 总分变化量、改善率和日平均剂量如下。另外, 在比较试验中, PANSS总分量的变化与利培酮 (耐受)、该制剂和对照药物作为疗效主要评价项目的提高率 (= 10%)与氟哌啶醇的比较试验中得到了非隐性的验证。
包装
片剂
2毫克:[PTP] 100片(10片 x10)
4毫克:[PTP] 100片 (10片x10), 1000 片(10片x100)[瓶装]1000片
8毫克:[PTP] 100 片(10片x10), 1000片(10片x100)[瓶装] 1000 片
散2％
[瓶] 100克
制造和销售来源
大日本住友制药株式会社
注：以上中文不够完整，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/1179048B1025_1_18/
Released "Lonesen", a therapeutic agent for schizophrenia, Dainippon Sumitomo Pharma
Dainippon Sumitomo Pharma released the schizophrenia treatment agent "Lonesen tablets 2mg/4mg, 2% lonocene dispersion" (General Name: Bronanserin) from 22.
This is a new structure created by Dainippon Sumitomo Pharma, a therapeutic agent for schizophrenia.
The agent has a strong blocking action and high selectivity for dopamine-2 receptors and serotonin-2 receptors, characterized by a strong blocking effect on dopamine-2 receptors from serotonin-2 receptors.
In clinical trials, positive symptoms of schizophrenia (hallucinations, delusions, etc.) not only, negative symptoms (such as monotony of emotion, decreased motivation) has been shown to improve the effect.
Also, the incidence of extrapanidal symptoms is low, the side effects such as weight gain and high prolactinemia is also obtained is small results. The lifelong preva lence of schizophrenia is 0 and 8%, and there are more than one million patients in our country.
At the onset of the late teens and early thirties, there are many cases where the incidence is not gender-rich, but the onset of males is young. In addition, the cause and condition of schizophrenia, positive symptoms dopamine excess, negative symptoms are caused by dopamine deficiency "dopamine hypothesis" has become mainstream. The main feature of Lonensen is the strong dopamine-blocking action, which has the requirement as a first drug second-generation antipsychotic (atypical antipsychotic) with a high dopamine affinity, and can be expected to effect on positive symptoms such as hallucinations and delusions.
Because it has a balanced safety profile, it can transition smoothly to the maintenance phase treatment-such as.
As with the company's atypical anti-psychotic drug Luran, Lonesen will jointly promote Mitsubishi Tanabe Pharma's consolidated subsidiary with Yoshitomi Chemicals, a promotional activity specializing in psychiatric areas. Dainippon Sumitomo Pharma has positioned the mental nerve domain as one of the research-oriented areas, and has established a full-time MR in the business side and is focusing on the future as one of the core areas.
In addition to Lonesen, Luran, the company's schizophrenia therapeutics include a form of antipsychotics. Dainippon Sumitomo Pharma's CNS dedicated MR is 80 people, and the MR of Yoshitomi Pharmaceutical is 190 people. In the future, in the acute phase of hallucinogenic delusion in the two companies, the company will promote the use of Luran (sold in 2001) during the period of maintenance treatment and maximize the early Lonesen.
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附件:
20109720285835.pdf
201022017240940.pdf |
