不同药用部位及制备工艺对柴胡注射液质量的影响

目的:研究北柴胡不同药用部位及制备工艺对柴胡注射液质量的影响,为该制剂的临床安全应用提供参考。方法:分别将北柴胡的地上部分、地下部分及全草采用蒸馏、加盐蒸馏、加酸蒸馏和加酸加盐蒸馏工艺进行制备,按法定质量标准(WS3-B-3297-98-2011)对其检测分析。结果:北柴胡不同药用部位对特征图谱判定的结果影响不大,但不同色谱峰之间的比例存在明显差异;不同制备工艺对特征图谱的影响非常明显;其他检测项目均符合法定标准要求。结论:采用正常工艺制备的样品均未检测出糠醛,非正常工艺的样品80%含有糠醛,而不同药用部位对柴胡注射液的质量影响比较小,说明目前的法定质量标准不能够有效地控制产品质量,需对不同药用部位生产的柴胡注射液加以控制,以保证产品质量。

Effect of Different Medicinal Parts and Preparation Processes on Quality of Chaihu Injection

Objective: To investigate effect of different medicinal parts and preparation processes of Bupleurum chinense on quality of Chaihu injection. Method: Part on the ground,the underground part and the whole grass of B. chinense were extracted by distillation,distillation with salt,distillation with acid,distillation acid and salt,extract were detected and analyzed by the legal quality standard of WS₃-B-3297-98-2011. Result: Different parts of B. chinense had little effect on characteristic spectrum determination results,but proportion between different chromatographic peaks in fingerprint had obvious difference;effect of different preparation processes of fingerprint was very obvious;other test items conformed to the legal standard requirements. Conclusion: Samples prepared by the original process do not detect furfural,samples of non-original process contain furfural.Different medicinal parts have small impact on quality of Chaihu injection.The current legal quality standard can not effectively control product quality,in order to ensure product quality,quality standard of Chaihu injection must revise.