高效液相色谱法和生物效价测定法在缩宫素注射剂质量控制中的对照研究

A comparative study on the quality control of oxytocin injection by HPLC and BA

目的采用高效液相色谱法（HPLC）对缩宫素注射剂进行质量控制,同时与传统的生物效价测定法进行比照,观察两种方法的优劣。方法选取8个企业生产的100个批次的缩宫素注射剂,分别采用HPLC法和生物效价法对样本进行测定,并将结果进行比较,并进一步观察样品的长期稳定性。结果两种方法检测的缩宫素含量除两家药企外（P=0.027、P=0.011）,其他企业生产的缩宫素含量差异无统计学意义（P=0.556、0.637、0.614、0.559、0.315、0.429）;8家药企的缩宫素注射剂含量在55.9%-126.1%之间,平均98.5%,其中有三个企业生产的缩宫素注射剂含量相对偏低;缩宫素注射剂储存2年后其效价显著降低,差异有统计学意义（P=0.025）。结论采用HPLC法对缩宫素注射剂测定,操作相对简便,灵敏度和准确度高,有效避免了生物效价测定法因动物个体差异造成的误差,同时也能将人为测定的误差控制在较小的范围内。另缩宫素注射剂最佳存贮期为2年,时间过长会导致药剂中部分有效成分降解。

Objective To compare the advantages and disadvantages of HPLC and BA which control the quality of oxytocin injection.Methods We selected 100 batches of oxytocin injection which were produced by 8 enterprises,chose HPLC and BA to measure the samples and compared the test results. Results Differences between the two methods for detecting the oxytocin levels in oxytocin injection produced by two companies were significant（ P = 0. 027,P = 0. 011）,while differences among other oxytocin injection manufacturers were not statistically significant（ P = 0. 556,0. 637,0. 614,0. 559,0. 315,0. 429）. The oxytocin injection content of 8 pharmaceutical companies were within 55. 9% - 126. 1%,averaged 98. 5%. The contents of oxytocin injection produced by three enterpriseswere relatively low. After 2 years of storage,the titer of oxytocin injection was significantly decreased with statistically significant difference（ P = 0. 025）. Conclusions HPLC used to determine oxytocin injection is relatively simple,sensitive and accurate,which can not only effectively avoid the error due to individual differences of BA,but also control human error of determination within a small range. Besides,the best storage duration for oxytocin injection is 2 years.