小儿用复方林可霉素滴鼻液的制备及质量控制

Preparation and Quality Control of Compound Lincomycin Nasal Drops for Children

目的:制备小儿用复方林可霉素滴鼻液并建立其质量控制方法。方法:以盐酸林可霉素为主药配制滴鼻液;采用旋光法测定其中主药含量,并考察室温留样12个月内的药物含量及其稳定性,同时用家兔做鼻黏膜刺激性实验。结果:所制制剂为无色澄明液体,且鉴别、检查等均符合2005年版《中国药典》相关规定;盐酸林可霉素检测浓度的线性范围为3.2～20.0mg.mL-1(r=0.999 9) ,平均回收率为100.6%(RSD=0.69%) ;该制剂对鼻黏膜的刺激性小,室温贮存12个月内稳定。结论:该制剂处方工艺简便可行,质量可控。

OBJECTIVE： To prepare compound lincomycin nasal drops for children and establish a quality control method for this preparation. METHODS： Compound lincomycin nasal drops for children were prepared using lincomycin hydrochloride as main component with its content determined by polarimetry. The content and stability of the preparation within 12mon under room temperature were investigated. Meanwhile irritating test of rabbits＇ nasal mucosa was conducted. RESULTS： The prepared eye drops were limpid colorless liquid and it met the related standards stated in China Pharmacopeia （2005 edition） in identification as well as tests etc. Lincomycin hydrochloride showed a good linear relation in the range of 3.2--20.0mg · mL^ 1 （r = 0.999 9）, with average recovery at 100.6% （RSD = 0.69% ）. This preparation showed a little irritation on nasal mucosa, and it was stable within 12mon under room temperature. CONCLUSIONS： This preparation is simple and feasible in preparation technology and controllable in quality.