CAJ | 학술논문

目的：通过评价柴胡注射液质量现状和开展指纹图谱研究，为提升本品的质量标准、保证药品的安全性和有效性及开展柴胡注射液“效-毒”物质基础研究提供依据。方法依据现行卫生部部颁标准，采用气相色谱法测定不同厂家及批次柴胡注射液的糠醛含量；比较不同厂家及批次柴胡注射液特征指纹图谱的差异。结果不同厂家及批次的柴胡注射液糠醛含量有不同程度的差异；柴胡注射液指纹图谱在19 min 前所含色谱峰的数目和峰面积上存在显著差异。结论目前柴胡注射液的糠醛含量基本符合现行标准要求，方法可用于测定不同来源的柴胡注射液色谱指纹图谱，但有必要进一步加强柴胡注射液的毒性物质基础研究，为构建“效-毒”关联评价的柴胡注射液综合质量控制体系奠定基础。
목적：통과평개시호주사액질량현상화개전지문도보연구，위제승본품적질량표준、보증약품적안전성화유효성급개전시호주사액“효-독”물질기출연구제공의거。방법의거현행위생부부반표준，채용기상색보법측정불동엄가급비차시호주사액적강철함량；비교불동엄가급비차시호주사액특정지문도보적차이。결과불동엄가급비차적시호주사액강철함량유불동정도적차이；시호주사액지문도보재19 min 전소함색보봉적수목화봉면적상존재현저차이。결론목전시호주사액적강철함량기본부합현행표준요구，방법가용우측정불동래원적시호주사액색보지문도보，단유필요진일보가강시호주사액적독성물질기출연구，위구건“효-독”관련평개적시호주사액종합질량공제체계전정기출。
Objective By evaluation of the quality of Bupleurum injection and study on its fingerprints, to provide evidence to enhance the quality standards of the product, ensure safety and efficacy and carry out material basis research of "toxicity-effection" for Bupleurum injection. Methods Under the current Ministry of Health ministerial standards, using gas chromatography to determinate Bupleurum injection's furfural content of different manufacturers and batches, compare the differences of Bupleurum injection fingerprint characteristics of different manufacturers and batches. Results Bupleurum injection furfural content of different manufacturers and batches is different. The number of peaks and the peak area before the 19 minutes in Bupleurum injection fingerprints exist significant differences. Conclusion Currently furfural content of Bupleurum injection conform with the current standard, Bupleurum injection chromatographic fingerprint method can be used to determine the different sources. To lay the foundation of the evaluation of Bupleurum injection for the construction of a comprehensive quality control system on "effection-toxicity" related patterns, it's necessary to further strengthen the toxic material basis research for Bupleurum injection.