目的 建立热毒宁注射液的紫外指纹图谱，提升其质量标准。方法 采用紫外可见分光光度计扫描15批热毒宁注射液全波长图谱，建立对照指纹图谱，用相关系数法计算样品紫外指纹图谱与对照指纹图谱的相似度，并对14批样品进行验证。结果 5批效期内的热毒宁注射液，其紫外指纹图谱符合要求，相似度均高于0.902，且吸光度值满足323 nm（0.693~0.781 Abs）、267 nm（0.323~0.370 Abs）、236 nm（0.957~1.067 Abs）、226 nm（0.902~1.013 Abs）、218 nm（0.953~1.075 Abs）、211 nm（0.926~1.052 Abs）；另外过期的9批样品，其相似度低于0.902或吸光度值不满足上述要求。结论 紫外指纹图谱法可作为一种简单准确的质量评价方法用于控制热毒宁注射液的质量。

Objective To establish the quality standards of Reduning Injection (RI) based on UV fingerprint, and improve the quality standards of RI. Methods Full wavelength UV-vis spectrophotometer was used to scan the 15 batches of RI, a reference fingerprint was established, correlation coefficient method was used to calculate RI sample fingerprint and control fingerprint similarity, and the 14 batches of samples were verified. Results The five batches of RI were within the validity period, their UV fingerprints were in line with the requirements, similarity was all above 0.902, while the absorbance values were in the ranges of 0.693-0.781 (323 nm), 0.323-0.370 (267 nm), 0.957-1.067 (236 nm), 0.902-1.013 (226 nm), 0.953-1.075 (218 nm), and 0.926-1.052 (211 nm); In addition the expired nine batches of RI, similarity is less than 0.902 or the absorbance value does not meet the standard. Conclusion UV fingerprint method can be used as a simple and accurate method of quality evaluation for the quality control of RI.

四川省千人计划（2013332）