复方苯海拉明麻黄碱滴鼻液的处方改进及质量控制

Compound Diphenhydramine Hydrochloride Nasal Drops Prescription Improvement and Quality Control

目的探讨复方苯海拉明麻黄碱滴鼻液的处方改进及其质量控制。方法以盐酸苯海拉明、盐酸麻黄碱,呋喃西林为主药,配制成滴鼻剂,并考察质量标准和临床疗效。结果回收率实验结果显示,盐酸苯海拉明和盐酸麻黄碱总量、呋喃西林含量平均回收率分别为100.30%、100.30%,RSD分别为0.15%、0.07%;放置180 d其性状,pH值、含量无明显变化;临床疗效观察总有效率为96.26%。结论处方改进后的制剂组方科学合理,配制工艺简便,质量易控和性质稳定,经临床应用疗效确切,不良反应小,值得推广应用。

Objective： To investigate the compound diphenhydramine hydrochloride nasal drops to improve the prescription and quality control. Methods： diphenhydramine hydrochloride, ephedrine hydrochloride, Nitrofurazone mainly drugs, the preparation of nose drops, and inspected the quality standards and clinical efficacy. Results： The Results showed that the recovery, diphenhydramine hydrochloride, and ephedrine hydrochloride total, Nitrofurazone in average recoveries were 100.30%, 100.27%, RSD were 0.15%, 0.07%; at 180 d of its characters, PH value, There was no significant change; Clinical Observation of the total efficiency of 96.26 % Conclusion： prescription improved formulations set of scientific and reasonable,the preparation process is simple, easy to control the quality and nature of stability, and the clinical application of precise, side effects, it is widely used.