摘要
目的:优选姜黄素滴丸的成型工艺,并对滴丸进行质量评价。方法:以硬度、圆整度、拖尾和粘连度的评分为评价指标,采用单因素试验对基质种类、基质与药物的配比、滴制温度、冷凝剂温度进行初步筛选;以姜黄素与聚乙二醇4000(PEG4000)的配比、滴制温度、冷凝剂温度为考察因素,采用正交试验优选姜黄素滴丸的成型工艺,并对制备的滴丸进行含量测定,丸重差异、溶散时限检查和加速、长期试验。结果:姜黄素滴丸的最佳成型工艺为:以PEG4000为基质,姜黄素与PEG4000的配比为1∶5.5(m/m),滴制温度为85℃,冷凝剂温度为4℃;每粒滴丸含姜黄素3.1752mg,滴丸的丸重差异为-6.2%～7.8%,且在5.5min内全部溶出,加速6个月和长期24个月试验中各项指标均未出现明显变化。结论:所选成型工艺合理、可行,可制备质量合格的姜黄素滴丸。
OBJECTIVE： To optimize the forming process of Curcumin dripping pills and to evaluate the quality of it. METH- ODS： Single factor test was used to screen matrix type, the proportion of matrix to drug, the temperature of making dripping pill and the temperature of cooler using solidity, roundness, tailing and adhesion degree as index. The forming technology of curcumin was optimized by orthogonal test using the proportion of PEG4000 to curcumin, the temperature of making dripping pill and the temperature of cooler as factors. The content of prepared dripping pills was determined, and the difference of pill weight, dissolving time test, acceleration test and long-term test were also conducted. RESULTS： The optimal forming process was as follows： PEG 4000 as matrix, the proportion of PEG4000 to curcumin 1：5.5（m/m）, the temperature of making dripping pill at 85 ℃, the tempera- ture of cooler at 4 ℃.The content of curcumin was 3.175 2 mg in each pill, and the difference of dripping pills were -6.2%-7.8%. The dripping pills were dissolved completely within 5.5 min, and no significant change of above index was found in 6 months ac- celeration test and 24 months long-term test. CONCLUSIONS： The forming process is reasonable and feasible, and it can be used for the preparation of qualified Curcumin dripping pills.
出处
《中国药房》
CAS
CSCD
2013年第31期2929-2931,共3页
China Pharmacy
