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目的制备稳定合格的华蟾素注射乳剂,完善已有的含量测定方法,并对制剂的质量进行研究。方法采用高压乳匀法制备华蟾素注射乳剂,并在华蟾素注射液中5-羟色胺含量测定方法(WS3-B-3045-98)的基础上,建立准确、稳定、操作简便的华蟾素注射乳剂中指标性成分含量的测定方法.结果5-羟色胺含量的最佳测定条件为温度不低于20℃,且在加入显色剂后30~35 min内测定,乳剂中5-羟色胺含量为(11.25±0.54)mg.L-1;华蟾素注射乳剂的粒径为(87.7±16.1)nm,zeta电位为-23.7 mV,渗透压偏高渗,pH值为5.31,黏度为3.922×10-3Pa.s,Ke为2.5%。结论华蟾素注射乳剂各项指标基本符合《中华人民共和国药典》2005版静脉注射制剂及部颁标准中华蟾素制剂含量的要求。
Objective To prepare a stable and qualified cinobufacini injection and improve the existing methods for the determination of the content of cinobufacini injection. The quality of the preparation was also studied. Methods The cinobufagin injection was prepared by high-pressure homogenization and the accurate, stable and easy-to-operate Chinese toad was established based on the method of determination of serotonin in cinobufacini injection (WS3-B-3045-98) The results showed that the optimum conditions for the determination of serotonin were as follows: the temperature was not lower than 20 ℃, and the content of serotonin in the emulsion was determined within 30-35 minutes after adding the color reagent (11.25 ± 0.54) mg.L-1. The particle size of cinobufagin injection was (87.7 ± 16.1) nm and the zeta potential was -23.7 mV. The osmotic pressure was hypertonic. The pH value was 5.31 and the viscosity was 3.922 × 10-3Pa.s, Ke is 2.5%. Conclusion All the indexes of cinobufacini injection are basically in line with the requirements of the content of Chinese cinobufacini preparations of “Pharmacopoeia of the People’s Republic of China” in 2005 and intravenous preparations.