双黄连粉针剂（Shuanghuanglian Powder Injection，SHLPI）是由双黄连注射液（Shuanghuanglian Injection，SHLI）创新转化的中药粉针剂，解决了传统剂型稳定性低、活性成分易降解等问题，广泛用于呼吸系统感染及病毒性疾病的临床治疗。近年来，其过敏反应等不良反应报道增多，质量可控性与用药安全性受到广泛关注。通过以解析SHLPI物质基础、构建质量控制体系为核心，检索整合相关资料，梳理其化学成分、药理机制及质控技术应用成果，明确当前成分药效机制不明、质控标准覆盖不足等问题，为提升其质量稳定性与用药安全性提供思路，也为质量标准升级及二次开发提供科学参考。

Shuanghuanglian Powder Injection (SHLPI) is an innovative traditional Chinese medicine powder injection derived from Shuanghuanglian Injection (SHLI). It addresses the limitations of the conventional dosage form, such as poor stability and easy degradation of active ingredients, and has been widely used in the clinical treatment of respiratory system infections and viral diseases. In recent years, there has been an increasing number of reports on its adverse reactions, including allergic reactions, raising widespread concerns regarding its quality controllability and medication safety. Focusing on elucidating the material basis and establishing a quality control system for SHLPI, this study retrieves and integrates relevant data to summarize the research advances in its chemical components, pharmacological mechanisms, and the application of quality control technologies. It also identifies current challenges such as unclear pharmacodynamic mechanisms of certain components and inadequate coverage of quality control standards. This work aims to provide insights for improving the quality stability and medication safety of SHLPI, as well as scientific references for the upgrading of quality standards and secondary development.

R283

国家中药材产业技术体系（CARS-21）