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目的:建立增塑剂丁酰柠檬酸三正己酯(butyryl trihexyl citrate,BTHC)的测定方法,并测定血小板贮存袋所含增塑剂BTHC在混合浓缩血小板保存过程中的溶出量,为该产品的安全性评价提供依据。方法:采用乙腈沉淀血小板悬液中的蛋白等杂质,离心所得上清液用高效液相色谱法(HPLC)测定BTHC的含量,并对测定方法进行方法学研究。结果:HPLC方法测定BTHC浓度在10~502μg·m L~(-1)范围内线性关系良好(r=0.999 9),灵敏度为0.04μg,仪器精密度RSD<5%,回收率为98.6%±8.4%,用该方法测定血小板贮存袋贮存一个治疗剂量的混合浓缩血小板时BTHC的溶出量,贮存第5天溶出量为28.10±2.38 mg;贮存第7天溶出量36.63±3.89 mg。结论:本法经方法学验证,可以用于测定BTHC在血小板悬液中的溶出量。
OBJECTIVE: To establish a method for the determination of butyryl trihexyl citrate (BTHC), a plasticizer, and to determine the dissolution rate of BTHC, a plasticizer contained in the platelet storage bag, during the storage of mixed concentrated platelets Provide a basis for safety evaluation. Methods: Acetonitrile was used to precipitate the protein and other impurities in the platelet suspension. The supernatant was centrifuged to determine the content of BTHC by high performance liquid chromatography (HPLC) and the methodological study was carried out. Results: The linearity was good (r = 0.999 9), the sensitivity was 0.04μg, the RSD was less than 5% and the recovery was 98.6% ± in the range of 10 ~ 502μg · m L -1 by HPLC method. 8.4%. The amount of BTHC released by the platelet in the storage plate of the platelet when storing a therapeutic dose of mixed concentrated platelets was 28.10 ± 2.38 mg on the fifth day and 36.63 ± 3.89 mg on the seventh day. Conclusion: This method is validated by methodology and can be used to determine the amount of BTHC released from platelet suspensions.