蛋白质包被PVDF膜吸附法检查中药注射剂缩合鞣质

Detection of condensed tannin in herb injections by use of protein coated PVDF membrane

目的试图建立一种操作简便、检查限量极低并适合中药注射剂缩合鞣质检查方法。方法将蛋白质包被的PVDF膜片安装在一滤过孔径为2 mm的过滤装置上,将一定体积的中药注射剂溶液通过蛋白质包被PVDF膜,用有机溶剂脱去杂色,根据膜片颜色深浅判断缩合鞣质限量。结果当通过蛋白质包被PVDF膜的样品体积为0.5 mL时检查限量约为0.07 mg/mL,检查限量低于2010年版《中华人民共和国药典(一部)》。本法能直接检测出4种上市中药注射液(清开灵注射液、双黄连注射液、丹参注射液和灯盏细辛注射液)存在微量缩合鞣质。结论本法操作简便并具有较强的抗干扰能力,检测限低,可以用于中药注射剂微量缩合鞣质限量的严格控制。

AIM To develop a sensitive method for detecting condensed tannin in herb injections.METHODS Polyvinylidene fluoride（PVDF） membrane coated with protein was installed on a filtering device with holes of 2 mm in diameter.The solution sample was filtrated through the PVDF membrane.The membrane was washed with methanol or other organic solvents to remove the stained color not caused by condensed tannin.The blot color intensity in the membrane was related to the condensed tannin content in the sample.RESULTS The detection limit of this method was about 0.07 mg/mL of condensed tannin in 0.5 mL sample.The method was able to keep from interference caused by other color components not from condensed tannin.The method even detected condensed tannin in four herb injections（Qingkailing Injection,Shuanghuanglian Injection,Danshen Injection and Dengzhan Xixin injection） from the market.CONCLUSION The results suggested that the method be useful to control condensed tannin in Chinese materia medica injections.