黄芩注射液的制备工艺及质量标准的初步研究

目的:研制以黄芩和柴胡为主药的注射剂,并建立质量控制标准。方法:以传统的水提醇沉法制备该注射剂,采用薄层色谱法对黄芩甙进行鉴定,并用紫外分光光度法测定黄芩甙的含量。结果:采用水提醇沉法制备得到的该注射剂符合药典关于注射剂的各项检查。实验结果表明:黄芩苷含量在1.6μg/mL～8.0μg/mL与吸光度成良好的线性关系,相关系数0.9996,平均回收率99.4%,相对标准偏差为0.6%(n=5)。黄芩甙的薄层色谱鉴别,薄层色谱斑点清晰、空白无干扰,重现性好。结论:该制剂生产工艺简单,质量标准简单易行,产品质量容易控制。

Preliminary Research on Preparation and Quality Criteria of Baicalin Injection

Prepare baicalin injection and formulate its quality criteria. Adopt UV spectrophotometrie to determine the concentration of baicalin, and TLC methods to analyze baicalin of the injection prepared by orthodox ethanol subsiding method. The injection prepared by orthodox ethanol subsiding method corresponds with the requisite inspection items of injection, and we have set up its quality control standards by UV spectrophotometrie and TLC methods. It indicated that the linear range of baicalin was 1.6 μg. mL-1 to 8.0 μg. mL-1, The average recovery was 99.4% with the RSD 0.6% （n=5）. The speckles of TLC method were distinct, accurate and sensitive. The technology of preparing the injection is simple. The quality criteria of the injection is easy and feasible. The quality of products is controllable.