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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。
Objective: To prepare Qingmaishen Pineal Nasal Fluid and establish its quality control method. Methods: Gentamicin sulfate, ephedrine hydrochloride and other drugs as main drugs, adding appropriate amount of hydrocortisone acetate, phenylephrine hydrochloride and suspending agent preparation nasal drops, using high performance liquid chromatography determination of ephedrine hydrochloride Content. Results: The prepared nasal drops were white suspension and the examination was in accordance with the relevant provisions of the 2005 edition of Chinese Pharmacopoeia. The linear range of the measured concentrations of ephedrine hydrochloride was 0.390-1.560 mg · mL- (1r = 0.9999) The recovery was 100.2% (RSD = 1.30%). Conclusion: The preparation process is simple and feasible, the content determination results are stable and the quality controllable.