注射用头孢硫脒与四种常用注射液的配伍稳定性考察

目的 考察注射用头孢硫脒在4种临床常用注射液中的配伍稳定性.方法 根据《中华人民共和国药典》(2010版)规定的注射液pH值的上下限,调节0.9％氯化钠注射液、5％葡萄糖注射液、10％葡萄糖注射液以及5％葡萄糖+0.9％氯化钠注射液的pH值,并按临床常用剂量,配制头孢硫脒与上述注射液及原pH值注射液的配伍溶液,考察上述12种配伍液于0、0.5、1、2、3、4、5、6h的pH值、颜色和澄明度等外观变化,用高效液相色谱法考察在上述时间点下配伍液中头孢硫脒的含量变化.该方法采用BDS-C18(250 mm×4.6 mm,5 μm)色谱柱,磷酸盐缓冲液:乙腈(80∶20)为流动相,检测波长为254 nm,柱温为30℃,进样量1μl.结果 头孢硫脒专属性好,能达到基线分离,线性范围为1～12 mg/ml(R=1.0000),日内精密度相对标准差＜2.0％,12种配伍液在6h内峰面积变化均＜4％.结论 头孢硫脒与不同pH值的0.9％氯化钠注射液、5％葡萄糖注射液、10％葡萄糖注射液以及5％葡萄糖+0.9％氯化钠注射液配伍后稳定,临床上可配伍使用.

Compatible stability study of cefathiamidine for injection with four infusions

Objective To study the compatible stability of cefathiamidine for injection with four infusions with different pH values. Methods According to the pH range of four infusions in China pharmacopoeia（CP） , pH of 0. 9% sodium chloride injections, 5% dextrose injections, 10% dextrose injections and 5% dextrose ＋ 0. 9% so- dium chloride injections were adjusted. According to the clinical common dose, the compatibility solutions between cefathiamidine and infusions and infusions unadjusted were confected, pH value, color and external appearance changes （ color and clarity） of the 12 compatibility solutions were determined at 0, 0.5, 1, 2, 3, 4, 5 and 6 h. The high performance liquid chromatography （HPLC） assay was performed for determining the content of the four compatibility solutions at the same time. BDS-C18 chromatographic column （250 mm x4. 6 mm,5 μm） was used; the mobile phase was phosphate buffer liquid and acetonitrile （80： 20） ; the detective wavelength was 254 nm; the temperature was 30℃ and the incoming sample amounted to 1 p,1. Results This method achieved baseline separation. The linear range was within 1-12 mg/ml. Relative standard deviation（RSD） of intra-day was less than 2%. Peak area was relative steady and decreasing degree was less than 4% within 6 hours. Conclusion After the compatibility of cefathiamidine and 0.9% sodium chloride injection, cefathiamidine and 5% dextrose injection, cefathi-amidine and 10% dextrose injection and cefathiamidine and 5% dextrose ＋0. 9% sodium chloride injection with different pH values during 6 hours at room temperature can keep an relative stability and can be used for clinic.