摘要
目的:筛选和优化金钱草配方颗粒提取、浓缩、干燥和制粒的工艺方法及参数。方法:以槲皮素和山柰素总提取率和干膏得率为指标,采用正交试验筛选提取工艺参数;以槲皮素和山柰素的总含量的稳定性筛选浓缩温度;以含水量、槲皮素和山柰素总含量、浸膏粉得率为指标,采用正交试验筛选喷雾干燥工艺参数;采用颗粒得率和颗粒性状筛选干法制粒工艺参数。对优选参数进行验证试验。结果:优化后的金钱草配方颗粒制备工艺为金钱草饮片加14、12、12倍量水,提取3次,每次0.5 h,80℃减压浓缩至相对密度1.08,喷雾干燥(进风温度120℃,雾化压力45 MPa)制成浸膏粉,加0.5%硬脂酸镁,混匀后干法制粒(送料螺杆转速为40 r/min,辊轮转速8 r/min,辊轮压力16 kg/cm^2)制成颗粒。验证试验结果显示各指标的RSD≤5.48%(n=3),槲皮素和山柰素总含量平均为2.43 mg/g。结论:优选的工艺稳定可行,可为金钱草配方颗粒的中试及大生产提供参考。
OBJECTIVE：To screen and optimize processing parameters of extraction,concentration,drying and granulation of Lysimachia christinae dispensing granules. METHODS：Taking extracting rate of quercetin and kaempferide,yield of solid extracts as indexes,orthogonal test was employed for optimize the extraction parameters. The temperature of vacuum concentration was screened by the stability of quercetin and kaempferide. The parameters of spry drying technology was screened by orthogonal test taking moisture content,the amount of quercetin and kaempferide,extract powder yield as evaluation indicator. The parameters of dry granulation were screened by granules yield and granules property. The optimized parameters were validated. RESULTS：The optimal preparation technology of L. christinae dispensing granules was as follows as adding 14,12 and 12 folds water,extracting for 3 times,lasting for 0.5 h each time;vacuum concentration temperature 80 ℃ and relative concentration density 1.08;powdered extract prepared by spray drying method（inlet air temperature of spry drying 120 ℃ and atomization pressure 45 MPa）,and mixed with 0.5% magnesium stearate to prepare granules by dry granulation（screw speed 40 r/min,roller speed 8 r/min,roller press16 kg/cm^2）. In validation test,RSDs of each indicator were all no more than 5.48%（n=3）,and average total content of quercetin and kaempferide was 2.43 mg/g. CONCLUSIONS：Optimized technology is stable and feasible,and it can provide guidance for scale-up and large-scale production of L. christinae dispensing granules.
出处
《中国药房》
CAS
北大核心
2016年第4期521-524,共4页
China Pharmacy
关键词
金钱草
配方颗粒
槲皮素
山柰素
制备工艺
喷雾干燥
干法制粒
正交试验
Lysimachia christinae
Dispensing granules
Quercetin
Kaempferide
Preparation technology
Spry drying
Dry granulation
Orthogonal test
