柴胡注射液化学成分分析与质量标准探讨  

Analysis of the Chemical Constituents of Chaihu Injections and Discussion on its Present Quality Standard

作　　者：姜勇[1] 鲍忠[1] 石子仪[1] 屠鹏飞[1] 

机构地区：[1]北京大学药学院天然药物及仿生药物国家重点实验室,北京100191

出　　处：《中国药品标准》2012年第5期332-335,共4页Drug Standards of China

基　　金：重大新药创制专项(20122X0901002-002-002;20122X09304-005)

摘　　要：目的:分析柴胡注射液主要化学成分,明确其质量标准中吸光度测定存在的问题,为柴胡注射液质量标准的提高与修订提供科学依据。方法:采用紫外分光光度法对柴胡注射液的吸光度进行测定;采用气相色谱和与参考物质对照方法对其化学成分进行分析。结果:柴胡注射液化学成分复杂,主要成分为脂肪醛类化合物,其现行质量标准〔检查〕项下在278 nm测定的吸光度主要是糠醛的贡献;注射液生产中加盐酸和氯化钠蒸馏的样品,糠醛含量明显提高。结论:柴胡注射液的现行质量标准无法控制其质量,建议修订柴胡注射液的质量标准,并建立糠醛的限量检查。Objective： To analyze the main chemical constituents in Chaihu Injections, and make clear the existing questions for the absorption determination in its present quality standard. These will supply some references for the revision of the quality standard of Chaihu Injections. Method： Ultraviolet spectrophotometry was used for the absorption determination, while GC and comparison with the references were used for the anlysis of the chemical constituents. Results： The chemical constitution of Chaihu Injections was complex, and the main detected constiuents were aliphatic aldehydes. If more hydroxylic acids and salts were added to the distil/ate in the production procedure, a higher content of furfural would be produced in the injections. The absorbance in 278 nm determined by the absorption test method recorded in the Drug Standard of Ministry of Health PRC was deduced to be mainly from the contribution of furfural. Thus, the absorbance of the distillate could easily reach the standard requirement even after the repeated distillation, which supplied the possiblity for the production of the adulterants. Conclusion： The old standard of Chaihu Injection can not control the qulity of the products effectively, so, the revision and improvement must be made, and the dose limit of furfural should be regulated.

关 键 词：柴胡注射液 化学成分 质量标准 紫外吸收 

分 类 号：R921.2[医药卫生—药学]