pH值对盐酸林可霉素输液的影响

Effect of the pH value on lincomycin hydrochloride injection

目的 考察不同pH条件对盐酸林可霉素输液的影响。方法 分别制备pH值为 6.0 ,6.5 ,7.0的林可霉素输液 ,于低温(4℃ )、高温 (60℃ )及强光照射 (45 0 0lx ,2 5℃ )等条件下考察了各输液的稳定性。HPLC测定了所考察样品的含量及降解产物等。结果 pH为 7.0样品的外观及澄明度度均不合格 ,高温 10d的含量下降 8%左右 ;而 pH为 6.0样品的外观、澄明度及药物含量、色谱降解产物均无明显变化 ;pH6.5样品的考察结果介于两者之间。HPLC含量方法回收率 :(99.8± 0 .8) % ;标准曲线 :Cmg/mL =1.84682 9X - 0 .0 85 5 2 6,r =0 .9996;最低检出限 :6ng。 结论 盐酸林可霉素输液的 pH为 6.0时 ,样品在强光、高温、低温等条件下均稳定。因此 ,输液的pH上限以 6.0为宜。

OBJECTIVE To observe the effect of pH value on lincomycin hydrochloride injection. METHOD The injection contained lincomycin hydrochloride was prepared with the pH value of 6.0?6.5?7.0, respectively. The samples were put at certain conditions(60℃?4℃ and light(4500Lx,25℃)) and the stability of the injection was observed. The content and the degradable substances of the injection were measured and identified by HPLC.RESULTS The clarity of the sample (pH7.0) didn't qualify, and the content of the injection (60℃,10d) decreased to 90.89%; for the sample with pH6.0, its clarity, content and degradable substances did not change significently during 10 days at three different conditions, and the injection with pH 6.48 , its stability was middling among these three samples. The recovery was 99.8%±0.8; the standard curve was Cmg/mL=1.846829x-0.085526, r=0.999 6, and the LD was 6ng. CONCLUSION When the pH value of lincomycin hydrochloride injection was 6.02, the sample was stable, and the limit value of upper pH should be 6.0.