丹参川芎嗪注射液细菌内毒素检查法研究

Study on Bacterial Endotoxin Test of Salviae Miltiorrhizae and Ligustrazine Hydrochloride

目的建立丹参川芎嗪注射液细菌内毒素检查法。方法依据《中国药典》2015年版四部(通则1143)细菌内毒素检查法,通过预干扰预试验和干扰试验,确定丹参川芎嗪注射液最大无干扰的浓度,并进行方法学验证。结果将丹参川芎嗪注射液稀释20倍,对细菌内毒素检测法无干扰作用。结论丹参川芎嗪注射液内毒素检查法可用于检查丹参川芎嗪注射液。

Objective Establish a bacterial endotoxin test for Salviae Miltiorrhizae and Ligustrazine Hydrochloride.Methods According to the Chinese Pharmacopoeia's2015edition of the four-part(General Rule1143)bacterial endotoxin test,the maximum interference-free concentration of Salviae Miltiorrhizae and Ligustrazine Hydrochloride was determined by pre-interference pre-test and interference test,and the methodological verification was carried out.Results The Salviae Miltiorrhizae and Ligustrazine Hydrochloride was diluted20times,which had no interference effect on the bacterial endotoxin test.Conclusion The endotoxin test of Salviae Miltiorrhizae and Ligustrazine Hydrochloride can be used to check Salviae Miltiorrhizae and Ligustrazine Hydrochloride.