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目的:探讨影响注射用头孢拉定/精氨酸含量测定准确性的因素。方法:通过对2批仲裁注射用头孢拉定/精氨酸的分析,按照中国药典2005年版方法测定头孢拉定含量,用HPCE法(内标法)测定精氨酸含量,同时考察杂质头孢氨苄含量、精氨酸含量、装量、样品的稳定性、样品的引湿性、样品溶解超声时间和取样方式对头孢拉定含量测定结果的影响,分析之间的相关性,寻找易造成头孢拉定/精氨酸含量测定结果偏差的主要原因。结果:由于终产品为头孢拉定和精氨酸的混合物,头孢拉定粉末和精氨酸粉未在物理性质上的差异会造成两者在样品瓶中的不均匀分布,从而导致头孢拉定和精氨酸含量测定结果之间存在较大的差异,5瓶样品之间头孢拉定含量测定结果极差可达近8%,RSD为3.0%。结论:复方制剂中头孢拉定和精氨酸的混合均匀性是引起含量测定结果差异的最主要原因。企业在生产过程中以及检验人员在检验过程中均可造成样品的混合不均匀。
Objective: To explore the factors influencing the accuracy of determination of cefradine / arginine for injection. Methods: The cefradine / arginine was determined by two batches of arbitration injection, the content of cefradine was determined according to the Chinese Pharmacopoeia 2005 edition, and the content of arginine was determined by HPCE method (internal standard method) Acid content, loading capacity, sample stability, sample wettability, sample dissolution time and sampling method on the determination of cefradin determination of the results of the correlation between the analysis to find easy to cause cefradine / arginine content determination of bias The main reason. Results: The difference in physical properties between cefradine powder and arginine powder resulted in an uneven distribution of the two in the sample vial resulting in the determination of cefradine and arginine due to the mixture of cefradine and arginine There was a big difference between the results. The determination of cephradine content among the 5 bottles of samples showed a very poor result of nearly 8% with a RSD of 3.0%. Conclusion: The mixing uniformity of cefradin and arginine in compound preparations is the most important reason for the difference of determination results. Enterprises in the production process and inspectors in the testing process can cause uneven mixing of samples.