5种注射剂的细菌内毒素检查法初步考察

Inspection on BET feasibility of five injections

目的:考察5种注射剂盐酸林可霉素注射液(a),盐酸精氨酸注射液(b),注射用玻璃酸酶(c),肝素钠注射液(d)和顺铂注射液(e)的细菌内毒素检查法可行性.方法:中国药典细菌内毒素检查法.结果:除d外,其余原液及稀释液均有干扰作用.结论:d的原液及a的20倍以上稀释液可用灵敏度为0.5EU/ml的鲎试剂作细菌内毒素检查,而b,c和e尚需进一步探讨.

OBJECTIVE: To inspect on the feasibility of bacterial endotoxin test (BET) for five injections, ie Licomycin hydrochloride injection(a),Arginine hydrochloride injection(b),Hyaluronidase for injection(c).Heparin sodium Injection(d) and Cisplatin injection (e). METHOD: BET of China pharmacopoeia. RESULTS: Different interferential effects were shown on these injectiones with the exception of (d).CONCLUSION:The original concentration of (d) andover 20 times dilution of (a) could be tested by tachpleus amebocyte lysate(TAL) with the sentivity of 0. 5EU/ml, and further investigation needs to be carried out on (b), (c) and (e).