苯巴比妥口服溶液的制备及质量控制

Preparation and Quality Control of Phenobarbital Oral Solution

目的:制备苯巴比妥口服溶液并建立其质量控制方法。方法:以聚乙二醇400、1,2-丙二醇及单糖浆等为辅料制备苯巴比妥口服溶液;采用化学鉴别法和电位滴定法等进行定性鉴别和定量测定。结果:所制备的苯巴比妥口服溶液性状、鉴别、有关物质、含量测定等各项指标均符合2010年版《中国药典》二部附录口服溶液剂的规定。结论:该制剂的制备工艺合理,所建定性、定量方法简便、准确、可靠。

OBJECTIVE： To prepare Phenobarbital oral solution and establish quality control method of it. METHODS ： Phenobarbital oral solution was prepared using PEG400, 1,2-propylene glycol and simple syrup. Chemical identification and potentiometric titration were used for qualitative identification and quantitative determination. RESULTS： The prepared Phenobarbital oral solution met the requirements of Chinese Pharmacopeia （2010 edition） on the aspects of character, identification, related substances, determination, and other indicators. CONCLUSION： The preparation technique of Phenobarbital oral solution is reasonable. The established methods of identification and determination are convenient, accurate and reliable.