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目的:选用3种含不同类别热原的非肠道用制品对家兔热原检查法(RPT)、细菌内毒素检查法(BET)和新的体外热原检查法(IPT)3种不同原理的热原检测方法进行比较研究,以期评价它们在制品检测中的准确性、可靠性和适用范围,为今后制品选择适宜的检查方法提供科学的依据,确保制品临床使用的安全性。方法:用3种热原检测方法分别对b型流感嗜血杆菌结合疫苗(Hib)、卡介菌多糖核酸注射液(BCG-PNA注射液)和红花注射液3种制品进行检测,以药典规定的人用热原限量标准为判断依据,比较3种方法所测制品中致热物质含量(相当于内毒素标准单位)之间的差异。结果:3种检查法检测Hib的结果均一致(为合格)[RPT法(<50 EU·mL-1)、BET法(4.63·mL-1)和IPT法(<1 EU·mL-1)],但检测BCGPNA注射液[在RPT法(<50 EU·mL-1)和IPT法(46.50 EU·mL-1)的结果均为合格,但BET法(4455.5 EU·mL-1)的结果为不合格]和红花注射液[RPT法(>2.5 EU·mL-1)的检测结果为不合格,而BET法(<0.3 EU·mL-1)和IPT法(<0.9EU·mL-1)的结果均为合格]的结果却有所不同。结论:Hib适用于3种检测方法,可考虑选用IPT法或BET法替代RPT法;BCG-PNA注射液适用于RPT法与IPT法,不适用于BET法,所以今后可能只有考虑选用IPT法替代RPT法;红花注射液目前最好还是使用RPT法对其进行热原检测。本研究也证明,对于BET法和IPT法的广泛应用还需要更多的研究与评价。
OBJECTIVE: Three different principles of RPT, bacterial endotoxin test (BET) and new extrinsic pyrogen test (IPT) were selected from three parenteral products containing different types of pyrogen. In order to evaluate their accuracy, reliability and application range in product testing, provide a scientific basis for the selection of suitable test methods in the future, and ensure the safety of clinical use of the product. Methods: Three kinds of pyrogen detection methods were used to detect three kinds of products of Hib, BCG-PNA, and Honghua injection, respectively. Pharmacopoeia Provisions of the people using the pyrogen limit standards as the basis for judging, comparing the three methods measured pyrogen content of the substance (equivalent to endotoxin standard unit) the difference between. Results: The results of three methods for detecting Hib were consistent (qualified) [RPT (<50 EU · mL-1), BET method (4.63 mL-1) and IPT (<1 EU · mL- ], But the results of BCGPNA injection [the results of the RPT method (<50 EU · mL-1) and the IPT method (46.50 EU · mL-1) were acceptable, but the results of the BET method (4455.5 EU · mL- (≤0.3 EU · mL-1) and IPT method (<0.9 EU · mL-1), and the results of RPT method (> 2.5 EU · mL- 1) the results are qualified] the results are different. Conclusion: Hib is suitable for three kinds of detection methods, IPT method or BET method can be considered instead of RPT method; BCG-PNA injection method is suitable for RPT method and IPT method, not for BET method, so in the future may only consider the choice of IPT method instead RPT method; safflower injection is best still use pyrogen test RPT method. This study also proves that more studies and evaluations are needed for the wide application of the BET and IPT methods.