药品结构化数据集

{
  "drug_id": "DRUG-2025-B8E4V9K2N7",
  "generic_name": "信迪利单抗注射液",
  "generic_name_en": "Sintilimab Injection",
  "brand_names": ["达伯舒","Tyvyt"],
  "approval_number": "国药准字SXXXXXXXX",
  "drug_category": "生物制品",
  "registration_class": "治疗用生物制品1类（创新药）",
  "rx_type": "RX（处方药）",
  "atc": {"code":"L01FF06","level1":"L 抗肿瘤药和免疫机能调节药","level2":"L01 抗肿瘤药","level3":"L01F 单克隆抗体和抗体药物偶联物","level4":"L01FF PD-1/PD-L1抑制剂","level5":"L01FF06 sintilimab"},
  "dosage_form": "注射剂",
  "strength": "10ml:100mg",
  "route": "静脉输注",
  "indications": {
    "approved": ["经典型霍奇金淋巴瘤（至少经过二线系统化疗）","非鳞状非小细胞肺癌（联合培美曲塞+铂类）","肝细胞癌（联合贝伐珠单抗类似物）"],
    "icd_codes": ["2B30.0","2C25.0","2C12.02"]
  },
  "administration": {"adult_usual":"200mg，静脉输注30-60分钟，每3周1次","max_daily":"200mg/次"},
  "adverse_effects": {"common":["发热","乏力","皮疹","甲状腺功能减退","ALT/AST升高"],"serious":["免疫相关性肺炎","免疫相关性肝炎","免疫相关性心肌炎","输注相关反应"]},
  "contraindications": ["对活性成分或任何辅料过敏者"],
  "pharmacology": {"class":"PD-1免疫检查点抑制剂","mechanism":"重组全人源抗PD-1单克隆抗体，阻断PD-1与PD-L1/PD-L2结合，恢复T细胞抗肿瘤免疫应答","target":"PD-1 (CD279)"},
  "clinical_trials": [
    {"ctr_number":"CTRXXXXXXXX","phase":"III","indication":"非鳞非小细胞肺癌","status":"已完成","sponsor":"信达生物制药","enrollment":397}
  ],
  "manufacturer": {"name":"信达生物制药（苏州）有限公司","mah":"信达生物制药"},
  "version": "2025Q2",
  "quality_score": 98.8
}

{
  "drug_id": "DRUG-2025-Z8C5Y3M1N2",
  "generic_name": "连花清瘟胶囊",
  "brand_names": ["连花清瘟","Lianhua Qingwen"],
  "approval_number": "国药准字ZXXXXXXXX",
  "drug_category": "中成药",
  "rx_type": "OTC（甲类）",
  "tcm_properties": {"nature":"寒","flavor":"苦、辛","meridian_tropism":["肺","胃"]},
  "dosage_form": "胶囊剂",
  "specification": "每粒装0.35g",
  "route": "口服",
  "ingredients": ["连翘","金银花","炙麻黄","炒苦杏仁","石膏","板蓝根","绵马贯众","鱼腥草","广藿香","大黄","红景天","薄荷脑","甘草"],
  "indications": {
    "approved": ["清瘟解毒，宣肺泄热。用于治疗流行性感冒属热毒袭肺证，症见发热或高热、恶寒、肌肉酸痛、鼻塞流涕、咳嗽、头痛、咽干咽痛、舌偏红、苔黄或黄腻等。"],
    "icd_codes": ["1E30"]
  },
  "administration": {"adult_usual":"一次4粒，一日3次"},
  "adverse_effects": {"common":["胃肠道不适","恶心","腹泻"],"rare":["皮疹"]},
  "contraindications": ["风寒感冒者不适用","对本品过敏者禁用"],
  "manufacturer": {"name":"石家庄以岭药业股份有限公司"},
  "package_insert_update": "2023-04-01",
  "version": "2025Q2",
  "quality_score": 97.5
}

{
  "drug_id": "DRUG-2025-A5R2T8W4N6",
  "generic_name": "头孢呋辛酯片",
  "generic_name_en": "Cefuroxime Axetil Tablets",
  "brand_names": ["西力欣","Zinnat"],
  "approval_number": "国药准字HXXXXXXXX",
  "drug_category": "化学药品",
  "registration_class": "化药4类",
  "rx_type": "RX（处方药）",
  "atc": {"code":"J01DC02","level1":"J 全身用抗感染药","level2":"J01 全身用抗菌药","level3":"J01D 其他β-内酰胺类抗菌药","level4":"J01DC 第二代头孢菌素","level5":"J01DC02 cefuroxime"},
  "dosage_form": "薄膜衣片",
  "strength": "0.25g（按C16H16N4O8S计）",
  "route": "口服",
  "is_antibiotic": true,
  "antibacterial_spectrum": "第二代头孢菌素，对G+球菌和部分G-杆菌有效，对β-内酰胺酶稳定",
  "indications": {
    "approved": ["急性咽炎/扁桃体炎","急性中耳炎","急性细菌性鼻窦炎","慢性支气管炎急性发作","单纯性尿路感染","单纯性皮肤和软组织感染"],
    "icd_codes": ["CA02.0","AB00.1","CA02","CA22.1","GC08.0"]
  },
  "administration": {"adult_usual":"0.25g，每日2次（q12h）","child":"按体重20-30mg/kg/日，分2次","timing":"餐后服用以增加吸收"},
  "adverse_effects": {"common":["腹泻","恶心","呕吐","皮疹"],"serious":["伪膜性肠炎","过敏性休克（罕见）"]},
  "interactions": [
    {"drug":"口服抗凝药（华法林）","severity":"监测INR","mechanism":"可能增强抗凝效果"}
  ],
  "contraindications": ["对头孢菌素类或青霉素类过敏者","既往有青霉素类即刻过敏反应史者"],
  "pharmacology": {"class":"头孢菌素类抗生素（第二代）","mechanism":"通过与细菌青霉素结合蛋白（PBPs）结合，抑制细菌细胞壁合成","microbiology":{"mssa":"S","streptococcus_pneumoniae":"S","h_influenzae":"S","moraxella":"S","e_coli":"S","pseudomonas":"R"}},
  "manufacturer": {"name":"葛兰素史克（GSK）","mah":"GlaxoSmithKline"},
  "version": "2025Q2",
  "quality_score": 98.5
}

{
  "drug_id": "DRUG-2025-C6N4X8F2K7",
  "generic_name": "硝苯地平控释片",
  "generic_name_en": "Nifedipine Controlled-release Tablets",
  "brand_names": ["拜新同","Adalat GITS"],
  "approval_number": "国药准字HXXXXXXXX",
  "drug_category": "化学药品",
  "registration_class": "化药4类",
  "rx_type": "RX（处方药）",
  "atc": {"code":"C08CA05","level1":"C 心血管系统","level2":"C08 钙通道阻滞剂","level3":"C08C 主要作用于血管的选择性钙通道阻滞剂","level4":"C08CA 二氢吡啶类衍生物","level5":"C08CA05 nifedipine"},
  "dosage_form": "控释片",
  "strength": "30mg",
  "route": "口服",
  "dosage_technology": "渗透泵控释系统（GITS），零级释放动力学",
  "indications": {"approved":["原发性高血压","慢性稳定型心绞痛（劳力性心绞痛）","变异型心绞痛"],"icd_codes":["BA00","BA40","BA41"]},
  "administration": {"adult_usual":"30mg，每日1次","max_daily":"60mg","timing":"整片吞服，不可掰开、嚼碎","caution":"肝功能不全者从30mg起始"},
  "adverse_effects": {"common":["头痛","面部潮红","踝部水肿","头晕","乏力"],"serious":["严重低血压","心绞痛加重（罕见）"]},
  "interactions": [
    {"drug":"CYP3A4强效抑制剂（伊曲康唑、克拉霉素）","severity":"禁忌","mechanism":"显著增加硝苯地平血药浓度"},
    {"drug":"葡萄柚汁","severity":"避免","mechanism":"抑制CYP3A4，升高血药浓度"}
  ],
  "contraindications": ["心源性休克","不稳定心绞痛（发作期）","急性心肌梗死（4周内）","妊娠20周以内"],
  "pharmacology": {"class":"二氢吡啶类钙通道阻滞剂","mechanism":"选择性阻断L型钙通道，扩张外周动脉和冠状动脉","pk":{"tmax_h":6,"half_life_h":7,"bioavailability":"45-75%（肝脏首过效应）"}},
  "manufacturer": {"name":"拜耳医药保健有限公司","country":"德国"},
  "version": "2025Q2",
  "quality_score": 99.0
}