Tianqing Ganmei (天晴甘美)天晴甘美
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
- 正大天晴药业集团股份有限公司Chinese legal name: 正大天晴药业集团股份有限公司
主要成分Active Ingredients
- 异甘草酸镁Yigan Caosuan Mei
药物知识说明
异甘草酸镁是一种在国家药监局注册认定的药品。标注生产企业为正大天晴药业集团股份有限公司。
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：正大天晴药业集团股份有限公司Chinese legal name: 正大天晴药业集团股份有限公司、正大天晴药业集团股份有限公司Chinese legal name: 正大天晴药业集团股份有限公司、正大天晴药业集团股份有限公司Chinese legal name: 正大天晴药业集团股份有限公司。
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: 天晴甘美) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 正大天晴药业集团股份有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 正大天晴药业集团股份有限公司Chinese legal name: 正大天晴药业集团股份有限公司, 正大天晴药业集团股份有限公司Chinese legal name: 正大天晴药业集团股份有限公司, 正大天晴药业集团股份有限公司Chinese legal name: 正大天晴药业集团股份有限公司.
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: 天晴甘美Recorded Chinese name: 天晴甘美
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 10ml∶50mg（以C42H60MgO16计）Recorded Chinese specification: 10ml∶50mg（以C42H60MgO16计）
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
- 正大天晴药业集团股份有限公司Chinese legal name: 正大天晴药业集团股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20051942
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H20051942
Manufacturer
Chinese legal name: 正大天晴药业集团股份有限公司 (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H20051942
生产企业
正大天晴药业集团股份有限公司(国产)
适应症
本品适用于慢性病毒性肝炎。改善肝功能异常。
用法用量
一日一次，一次0.1g（2支），以10%葡萄糖注射液250ml稀释后静脉滴注，四周为一疗程或遵医嘱。如病情需要，每日可用至0.2g（4支）。
不良反应
（1）假性醛固酮症：本品Ⅱ期Ⅲ期临床研究中未出现。据文献报道，甘草酸制剂由于增量或长期使用，可出现低钾血症，增加低钾血症的发病率，存在血压上升，钠、体液潴留、浮肿、体重增加等假性醛固酮症的危险，因此要充分注意观察血清钾值的测定等，发现异常情况，应停止给药。另外，作为低钾血症的结果可能出现乏力感、肌力低下等症状。（2）其它不良反应：本品Ⅲ期临床研究中出现少数病人有心悸（0.3%）、眼睑水肿（0.3%）、头晕（0.3%）、皮疹（0.27%）、呕吐（0.27%），未出现血压升高和电解质改变。
禁忌
严重低钾血症、高钠血症、高血压、心力衰竭、肾功能衰竭的患者禁用。
注意事项
1、治疗过程中，应定期测血压和血清钾、钠浓度。
2、本品可能引起假性醛固酮症增多，在治疗过程中如出现发热、皮疹、高血压、血钠潴留、低钾血等情况，应予停药。
贮藏
遮光，密闭保存。
规格
10ml∶50mg（以C42H60MgO16计）
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.