摘要
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。
To compare three pyrogen tests of different principles, the rabbit pyrogen test （RPT）, the bacterial endotoxin test（BET） and the new in vitro pyrogen test（IPT） in testing three parenteral medical products containing different pyrogens to evaluate the accuracy, reliability and applicable range of each test on detecting products, and provide scientific supports for future selection of appropriate methods to guarantee the safety of prod- ucts in clinical use. Methods：Pyrogen contents of haemophilus influenzae type b（Hib） conjugate vaccine, polysace- haridc nucleie acid fraction of bacillus calmette guerin injection （ BCG - PNA injection ） , and safflower injection were detected respectively by the three kinds of pyrogen detection methods listed above. According to the pyrogen content limit value of injection detection specified in Pharmacopoeia, the different content value of pyrogenic sub- stances（ equivalent to endotoxin standard unit）were compared among these three methods. Results：The test results showed that the results on Hib were the same（all passed）in all the three methods [ RPT（ 〈 50 EU · mL-1）, BET （4. 63 EU · mL-1） and IPT（ 〈 1 EU ·mL-1） ] ,but different on BCG- PNA injection [ the results of RPT（ 〈 50 EU · mL-1 ）and IPT（46.50 EU · mL-1 ）were passed,and the result of BET（4455.5 EU · mL-1 ）failed] and saf- flower injection [the result of RPT failed（ 〉2.5 EU · mL-1） ,but the results of BET（ 〈0. 3 EU · mL-1）and IPT （ 〈 0. 9 EU · mL - 1 ） were all passed ]. Conclusion： All the three pyrogen tests are suitable for Hib, and RPT can be replaced by IPT or BET. RPT and IPT except BET are suitable for BCG - PNA injection, therefore,in the future IPTcan only be considered to replace RPT. It may still be the best way to use RPT to test safflower injection at present. This study also indicates that it still needs more evaluations for wide application of BET and IPT.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第11期1971-1978,1983,共9页
Chinese Journal of Pharmaceutical Analysis
