摘要
目的制备舒咽康分散片,确定工艺流程。方法根据药物性质确定提取工艺,应用单因素试验和正交设计筛选舒咽康分散片的制备工艺,以片剂崩解时限、分散均匀性为考察指标,进行综合评分分析。结果采取醇水两提法得舒咽康稠膏,按20%比例加入微晶纤维素充分混合,60℃烘干,粉碎,过60目筛,得干浸膏粉,然后外加5%交联聚乙烯吡咯烷酮和0.3%微粉硅胶,混匀后进行粉末直接压片,控制片剂的硬度为3～4kg·cm-2。所制分散片可在3min内完全崩解并且全部通过2号筛,符合《中国药典》对分散片的要求。结论本品达到分散片要求,制剂质量稳定。
Objective To establish the preparation techniques of Shuyankang dispersible tablets. Methods The extraction process was set up based on the herbal properties. The preparation process was screened by single factor test and orthogonal design. A comprehensive scoring analysis was performed with disintegrating time and dispersible uniformity as the indexes. Results Shuyankang thick paste was extracted by alcohol and water, then added microcrystalline cellulose with the proportion of 20 %. After completely mixing, the mixture was dried at 60℃, crushed to cross the 60 eyelets sieve, thus the dry extract powder was obtained. The crosslinked polyvinyl pyrrolidon and Gum Acacia were added to the dry extract in the proportion of 5 % and 0. 3 %. After mixing, the mixture powder was made into tablets directly and the rigidity of the tablets was required in 3 -4 kg·cm^-2. The prepared dispersible tablet could be totally disintegrated within three minutes and crossed No. 2 sieve, which subjected to the Chinese pharmacopoeia . Conclusions The dispersible tablets are in accordance with the standard, and have stable quality.
出处
《中药新药与临床药理》
CAS
CSCD
2007年第4期326-328,共3页
Traditional Chinese Drug Research and Clinical Pharmacology
关键词
舒咽康
分散片
溶出度
Shuyankang
Dispersible tablets
Dissolution rate
