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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 its quality control method. METHODS: Nasal drops were prepared with lincomycin hydrochloride as the main drug. The content of the main drug was determined by polarimetry. The drug content and stability during 12 months at room temperature were also observed. At the same time, rabbits were given nasal mucosa stimulation Sexual experiment. Results: The preparation was colorless and clear liquid, and the identification and examination were in accordance with the relevant provisions of the 2005 edition of Chinese Pharmacopoeia. The linear range of lincomycin hydrochloride concentration was 3.2-20.0 mg.mL-1 (r = 0.999 9). The average recovery was 100.6% (RSD = 0.69%). The preparation showed little irritation to the nasal mucosa and was stable within 12 months of storage at room temperature. Conclusion: The formulation process is simple and feasible, quality controllable.