Recorded Chinese product: 盐酸布比卡因注射液盐酸布比卡因注射液
This is a medicine registration record from NMPA data.本页为国家药监局药品注册记录。
Labeled sections from the recorded Chinese source are included below. English wording is a reference translation when one is on file, not an official English label.本记录未接入产品级适应症/安全性标注字段。
生产企业Manufacturer
- 上海禾丰制药有限公司Chinese legal name: 上海禾丰制药有限公司
主要成分Active Ingredients
- 布比卡因Bubi Kayin
药物知识说明
布比卡因是一种在国家药监局注册认定的药品。标注生产企业为上海禾丰制药有限公司。
该药品暂无关联的活性成分信息。
该药品标注的生产企业为：上海禾丰制药有限公司Chinese legal name: 上海禾丰制药有限公司、上海禾丰制药有限公司Chinese legal name: 上海禾丰制药有限公司、上海禾丰制药有限公司Chinese legal name: 上海禾丰制药有限公司。
本页面内容来自国家药监局数据库，MedicineGraph在此基础上提供关系图谱和知识导航。
Medicine Knowledge
This medicine (original name: 盐酸布比卡因注射液) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 上海禾丰制药有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 上海禾丰制药有限公司Chinese legal name: 上海禾丰制药有限公司, 上海禾丰制药有限公司Chinese legal name: 上海禾丰制药有限公司, 上海禾丰制药有限公司Chinese legal name: 上海禾丰制药有限公司.
Source: MedicineGraph authoritative database. Relationships derived from registered product information.
这是什么What is this
- 通用名/品名Recorded product name: 盐酸布比卡因注射液Recorded Chinese product: 盐酸布比卡因注射液
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 5ml:37.5mg5 mL:37.5 mg
本段仅展示注册/说明书已记录的身份属性，不含适应症或用法建议。Identity attributes from registration/leaflet records only; no indications or usage advice.
生产企业Manufacturer
- 上海禾丰制药有限公司Chinese legal name: 上海禾丰制药有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H31022840
关联实体Relationships
信息来源Source and scope
国家药品监督管理局（中国）药品注册数据及已接入说明书字段。National Medical Products Administration (China) medicine-registration data and linked leaflet fields.
- 品名来源Name source: 10多万条药品说明书数据库 (HIGH)Package-insert database (more than 100,000 records) (HIGH)
- 生产企业来源Manufacturer source: 10多万条药品说明书数据库Package-insert database (more than 100,000 records)
- 剂型来源Dosage-form source: 10多万条药品说明书数据库Package-insert database (more than 100,000 records)
范围：当前 MedicineGraph 注册记录及已记录的精确关系；非完整目录，亦不构成疗效等同主张，也不支持换用判断。不含适应症/安全性推断。Scope: current MedicineGraph registration records and exact recorded relationships; not a complete catalog and not a claim of therapeutic equivalence. No inferred indications/safety.
本段为已核准说明书原文摘录（非改写、非AI摘要），非正式英文标签，亦不构成用药建议。 Not an official English label and not medical advice. English wording, when shown, is a reference translation of the Chinese source label.
English translation for reference. Translated from the Chinese source label. Not an official English label and not medical advice.
NMPA approval number
国药准字H31022840
Manufacturer
Chinese legal name: 上海禾丰制药有限公司 (domestically manufactured)
Indications
English translation unavailable. The original Chinese source label remains available below.
Dosage and administration
English translation unavailable. The original Chinese source label remains available below.
Adverse reactions
English translation unavailable. The original Chinese source label remains available below.
Contraindications
English translation unavailable. The original Chinese source label remains available below.
Precautions
English translation unavailable. The original Chinese source label remains available below.
Storage
Protect from light and keep tightly closed.
Specification
English translation unavailable. The original Chinese source label remains available below.
中文说明书原文Original Chinese source label
批准文号
国药准字H31022840
生产企业
上海禾丰制药有限公司(国产)
适应症
用于局部浸润麻醉、外周神经阻滞和椎管内阻滞。
用法用量
（1）臂丛神经阻滞，0.25%溶液，20-30ml或0.375%溶液，20ml（50-75mg）；（2）骶管阻滞，0.25%，15-30ml（37.5-75.0mg），或0.5%，15-20ml（75-100mg）；（3）硬脊膜外间隙阻滞时，0.25%-0.375%可以镇痛，0.5%可用于一般的腹部手术等。（4）局部浸润，总用量一般以175-200mg（0.25%，70-80ml）为限，24小时内分次给药，一日极量400mg；（5）交感神经节阻滞的总用量50-125mg（0.25%，20-50ml）；（6）蛛网膜下隙阻滞，常用量5-15mg，并加10%葡萄糖成高密度液或用脑脊液稀释成近似等密度液。
不良反应
（1）少数患者可出现头痛、恶心、呕吐、尿潴留及心率减慢等，如出现严重副反应，可静脉注射麻黄碱或阿托品。
（2）过量或误入血管可产生严重的毒性反应，一旦发生心肌毒性几无复苏希望。
禁忌
本品过敏者禁用。
注意事项
（1）本品毒性较利多卡因大4倍，心脏毒性尤应注意，其引起循环衰竭和惊厥比值较小(CC/CNS=3.7±0.5)，心脏毒性症状出现较早，往往循环衰竭与惊厥同时发生，一旦心脏停搏，复苏甚为困难。（2）局部浸润麻醉儿童用0.1%浓度。
贮藏
遮光，密闭保存。
规格
5ml:37.5mg
信息来源Source and scope
国家药品监督管理局（中国）药品注册数据。National Medical Products Administration (China) medicine-registration data.
范围：当前 MedicineGraph 注册记录及已记录的精确关系；非完整目录，亦不构成疗效等同主张，也不支持换用判断。Scope: current MedicineGraph registration records and exact recorded relationships; not a complete catalog and not a claim of therapeutic equivalence.