摘要
目的:在前期药效实验的基础上,提取麦芽总生物碱,优选麦芽总生物碱颗粒剂成型制备工艺,得到稳定均一,质量合格的颗粒制剂。方法:利用超声提取法,提取麦芽总生物碱;采用酸性染料比色法测定麦芽中总生物碱的含量;拟选6个处方完成颗粒剂的制备,并以休止角、成型率、堆密度和吸湿性等为指标,应用综合评分法对各处方进行打分,筛选出最优的辅料处方,完成辅料用量比例的优化,并筛选出最佳润湿剂;对制备所得到的麦芽总生物碱颗粒的溶化性,粒度及干燥失重等进行测定。结果:以糊精和乳糖比例为1∶1的混合物作为辅料,并按1∶1的比例混合麦芽总生物碱浸膏粉与辅料,选取80%的乙醇作为润湿剂,制备所得颗粒剂大小均一,成型率最高。结论:本文成功优选出了麦芽总生物碱颗粒剂的制备工艺,制成的颗粒溶化性好,成型率佳,制备方法稳定可靠。
OBJECTIVE On the basis of previous pharmacodynamic experiments,total malt alkaloids were extracted and the molding preparation process of total malt alkaloids granules was optimized to obtain stable and homogeneous granule preparations with qualified quality.METHOD Total malt alkaloids were extracted by ultrasonic extraction.the content of total alkaloids in malt was determined by acid dye colorimetry.6 formulations were selected to complete the preparation of granules,and the angle of repose,molding rate,bulk density and hygroscopicity were used as indicators to score each formulation using comprehensive scoring,select the optimal excipient formulation,complete the optimization of the dosage ratio of excipients,and select the optimal wetting agent.the solubility,particle size and loss on drying of the prepared malt total alkaloid granules were determined.RESULTS The mixture of dextrin and lactose in the ratio of 1∶1 was used as excipient,and malt total alkaloid extract powder and excipient were mixed in the ratio of 1∶1.80%ethanol was selected as wetting agent.The prepared granules had uniform size and the highest molding rate.CONCLUSION The preparation process of total malt alkaloid granules was successfully optimized,and the prepared granules have good solubility,good molding rate and stable and reliable preparation method.
作者
朱可敬
丁巧燕
王雄
吴金虎
ZHU Ke-jing;DING Qiao-yan;WANG Xiong;WU Jin-hu(College of Pharmacy,Hubei University of Traditional Chinese Medicine,Hubei Wuhan 430065,China;Central Laboratory,Tongren Hospital of Wuhan University/The Third Hospital of Wuhan,Hubei Wuhan 430065,China)
出处
《中国医院药学杂志》
CAS
北大核心
2020年第22期2291-2295,共5页
Chinese Journal of Hospital Pharmacy
基金
国家自然科学基金青年基金项目(编号:81603352)
湖北省自然科学基金项目(编号:2017CFB125)
湖北省中医药科研重点项目(编号:ZY2019Z013)
武汉市卫生计生委科研重点项目(编号:WZ16A10)。
关键词
颗粒剂
麦芽总生物碱
制备工艺
granule
malt total alkaloid
preparation process
