[关键词]
[摘要]
目的 以干姜Zingiberis Rhizoma醇提物为研究对象,研究表面改性、聚集与致孔相结合的共处理方式改善干姜醇提物的压片关键性能。方法 以共聚维酮(plasdone S-630,PVP/VA)和碳酸氢铵分别为改性剂和致孔剂,采用喷雾干燥共处理方法制备不同比例的干姜醇提物改性复合粉体,测定并比较各粉体的密度、流动性、粒径、孔隙率和压缩性等粉体学性质和抗张强度、屈服压、功和能等相关压片性质,并采用扫描电子显微镜(SEM)对各粒子表面形态进行表征。结果 仅加入共聚维酮或碳酸氢铵制备的复合粒子的孔隙率、抗张强度(TS)、有效功(Esp)和能(E2)均优于原粉粒子。此外,相比于碳酸氢铵或共聚维酮单独制备的复合粒子,碳酸氢铵-共聚维酮(7.0%、14.0%、21.0%)共喷雾制备的复合粒子所压制片剂的抗张强度进一步提升:分别为(1)3.8~9.7、4.0~12.5、4.2~13.7倍和(2)1.5~2.1、1.3~2.2、1.2~1.8倍。即同时加入共聚维酮和碳酸氢铵制备的多孔复合粒子使上述性质得到进一步改善。另外,崩解时间会随共聚维酮加入而有所延长(9~14 min),碳酸氢铵的致孔作用能够在一定程度上对此进行改善。SEM揭示了改性复合粒子的形态变化及致孔粒子表面存在的些许孔洞。结论 将干姜醇提物与共聚维酮和碳酸氢铵一起进行喷雾共处理能显著改善干姜原粉的粉体学和压片及片剂性质,可为一些中药提取物片剂制备性质的改善提供一个可行策略。
[Key word]
[Abstract]
Objective To study the effect of combined co-processing of surface engineering, aggregating and pore forming on the key tableting properties using alcoholic extract of Ganjiang (Zingiberis Rhizoma, ZR) as the research objects. Methods ZR engineering composite powders with different proportions was prepared by spray drying with plasdone S-630 (PVP/VA) as surface engineering agent and ammonium bicarbonate (NH4HCO3) as pore-forming agent. Powder properties (such as density, flowability, particle size, porosity, compressibility) and tablet properties (including tensile strength, yield pressure, work and energy) were measured and compared among the powders. Scanning electron microscopy (SEM) was applied to characterize the surface morphology of particles. Results The porosity, tensile strength (TS), effective work (Esp) and energy (E2) of the composite or porous particles with PVP/VA/NH4HCO3were superior to the parent powders of the ZR. Moreover, compared with composite particles with NH4HCO3 or PVP/VA, the TS of tablets prepared by composite particles with NH4HCO3 and PVP/VA (7.0%, 14.0%, 21.0%) was further improved (1) 3.8—9.7, 4.0—12.5, 4.2—13.7 times and (2) 1.5—2.1, 1.3—2.2, and 1.2—1.8 times, respectively. That is to say, these properties of the porous composite particles with PVP/VA and NH4HCO3 showed further improvements. In addition, the addition of PVP/VA prolonged the disintegration time of tablets to some extent (9—14 min), whereas the pore forming effect of NH4HCO3 could ameliorate this problem to a certain extent. The SEM revealed the changes in the morphology of the engineering composite particles and the pores on the surface of the porous particles. Conclusion Co-processing with PVP/VA and NH4HCO3 by spray drying could improve the powder, tablet and tableting properties of ZR, which provides a feasible choice for improving the tableting properties of some traditional Chinese medicine extract powders.
[中图分类号]
R283.6
[基金项目]
浙江省教育厅一般科研项目(Y202249945);宁波市科技计划公益类项目(202002N3146);宁波市自然基金项目(2018A610428);浙江药科职业大学校内课题一般项目(ZPCSR2012011)