华蟾素注射乳剂的制备及制剂质量的研究

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。

Preparation of Huachansu parenteral emulsion and studies on the quality of preparation

Objective To prepare stable and valid Huachansu (traditional Chinese medicine) intravenous emulsion, consummate the method of content determination and study the quality of preparation. Methods The Huachansu intravenous emulsion was prepared by the high pressure homogenizer method. The accurate, stable and convenient method of the content determination was built on the basis of the content determination of 5-HT in the injection (WS3-B-3045-98). Results The preferable colorimetric conditions were that: the absorbability was determined in 30-35 minutes after the developer was added and the temperature was not less than 20 ℃; the content of 5-HT in emulsion was (11.25±0.54) mg·L^-1; the particle size distribution of Huachansu parenteral emulsion was (87.7±16.1) nm, zeta potential was -23.7 mV, osmotic pressure was slightly higher than the osmotic pressure of human plasma, pH value was 5.31, viscosity was 3.922×10^-3 Pa·s, and K_e was 2.5%. Conclusion The Huachansu parenteral emulsion meets the requirements of intravenous preparation in China pharmacopoeia and Huachansu injection’s content in department standard.