柏子养心类制剂质量标准的研究进展

摘要：

【目的】柏子养心类制剂由柏子仁、党参、黄芪、川芎、当归等十三味药材组成，临床上常用于治疗心肾不交引起的心悸不宁、心烦少睡、梦遗健忘。《中华人民共和国药典》（简称《中国药典》）对柏子养心丸和柏子养心片有明确的质量要求，但现行质量控制方法还处于定性鉴别水平，含量测定指标单一甚至缺失，未对潜在毒性成分进行质量控制。【方法】通过查阅药典及相关文献，对柏子养心类制剂鉴别、含量测定、指纹图谱等方面研究进展进行归纳和综述。【结果】现有研究在定性鉴别方面补充了五味子等药材的薄层鉴别方法，并建立了多维指纹图谱以实现更全面的质量评价；在含量测定方面，建立了多种有效成分的定量分析方法，发现不同批次样品间质量差异显著；在安全性方面，部分研究指出制剂中朱砂所含汞元素存在潜在毒性风险。【结论】当前柏子养心类制剂的质量标准尚不完善，建议构建以功效成分群为核心的质量控制体系，加强毒性成分限量研究，并加快胶囊剂等剂型的标准制定，以确保药品的安全性、有效性和质量均一性。

Abstract:

[Objective] Baizi Yangxin preparations (BZYXs), which are prepared from 13 traditional Chinese herb medicines including Platycladi Semen, Codonopsis Radix, Astragali Radix, Chuanxiong Rhizoma, Angelicae Sinensis Radix, et al., are used for the treatment of palpitation, insomnia, amnesia and nocturnal emission caused by heart-kidney non-interaction. The Chinese Pharmacopoeia has definite quality requirements for Baizi Yangxin pills and Baizi Yangxin tablets. However, the current quality control methods is still at the stage of qualitative identification, content determination compound is single or even missing, and have not control the quality of potential toxic ingredient. [Methods] The study summarizes the research progress in BZYXs in the aspects of qualitative identification, fingerprint and content determination. [Results] Studies have supplemented TLC methods for identifying Schisandra chinensis and established multi-dimensional fingerprints for comprehensive quality assessment. Quantitative methods for multiple active components have been developed, revealing significant quality variations among different batches. Regarding safety, some studies indicated potential toxicity risksdue to mercury from cinnabar contained in the formulations. [Conclusion] The current quality standards for BZYXs are insufficient. It is recommended to establish a quality control system based on functional component groups, strengthen limits for toxic ingredients, and accelerate the development of standards for capsule and other dosage forms to ensure safety, efficacy, and batch-to-batch consistency.

引用格式：陈萌,杜玥瑾,侯非,等.柏子养心类制剂质量标准的研究进展[J].标准科学,2025(11):121-127.

作者简介：陈萌，博士，助理研究员，研究方向为中药新药研发与质量标准研究。付强，通信作者，博士，研究员，研究方向为健康服务与中医药标准化。