庆麻肾松滴鼻液的制备及质量控制

目的:制备庆麻肾松滴鼻液,并建立其质量控制方法。方法:以硫酸庆大霉素、盐酸麻黄碱等为主药,加入适量醋酸氢化可的松、盐酸去氧肾上腺素和助悬剂制备滴鼻液,采用高效液相色谱法测定其中盐酸麻黄碱的含量。结果:所制备的滴鼻液为白色混悬液,检查符合2005版《中国药典》中的相关规定,盐酸麻黄碱检测浓度的线性范围为0.390～1.560mg·mL-(1r=0.9999),平均回收率为100.2%(RSD=1.30%)。结论:本制剂制备工艺简便可行,含量测定结果稳定,质量可控。

Preparation and Quality Control of Qingma Shensong Nasal Drops

OBJECTIVE： To prepare Qingma shensong nasal drops, and to establish quality control method of it. METHODS： Gentamycin sulfate and ephedrine hydrochloride were used as main components, hydrocortisone acetate, phenylephrine hydrochloride and suspending agent were added into main components to prepare nasal drops. The content of ephedrine hydrochloride was determined by HPLC. RESULTS： The prepared nasal drops was white suspension, and the results of its tests were in conformity with the standards of Chinese Pharmacopeia （2005 edition）. The linear range of ephedrine hydrochloride was 0.390～1.560 mg·mL-1 （r=0.999 9） with an average recovery of 100.2% （RSD=1.30%）. CONCLUSION： The preparation technology for the nasal drops is simple and feasible, and the quality of the preparation is stable and controllable.