罗毓, 吴飞, 沈岚, 林晓, 冯怡. 流化包裹与致孔对中药提取物片剂制备性质的改善J. 药学学报, 2020,55(11): 2728-2735. doi: 10.16438/j.0513-4870.2020-1185
引用本文: 罗毓, 吴飞, 沈岚, 林晓, 冯怡. 流化包裹与致孔对中药提取物片剂制备性质的改善J. 药学学报, 2020,55(11): 2728-2735. doi: 10.16438/j.0513-4870.2020-1185
LUO Yu, WU Fei, SHEN Lan, LIN Xiao, FENG Yi. Improvement on the tableting properties of traditional Chinese medicine extracts by fluid-bed coating and pore formingJ. Acta Pharmaceutica Sinica, 2020,55(11): 2728-2735. doi: 10.16438/j.0513-4870.2020-1185
Citation: LUO Yu, WU Fei, SHEN Lan, LIN Xiao, FENG Yi. Improvement on the tableting properties of traditional Chinese medicine extracts by fluid-bed coating and pore formingJ. Acta Pharmaceutica Sinica, 2020,55(11): 2728-2735. doi: 10.16438/j.0513-4870.2020-1185

流化包裹与致孔对中药提取物片剂制备性质的改善

Improvement on the tableting properties of traditional Chinese medicine extracts by fluid-bed coating and pore forming

  • 摘要: 本文旨在研究包裹与致孔相结合的共处理对中药提取物压片及片剂相关性能的改善,并探究其对中药提取物的适用性。以4种中药提取物为研究对象,以羟丙基甲基纤维素(hydroxypropyl methyl cellulose,HPMC)和碳酸氢铵分别为包裹剂与致孔剂,采用流化床进行共处理,测定并比较各种粉体的粒径、粒径分布、松密度、振实密度、含水量等粉体学性质和抗张强度、压缩比、快速弹性复原、崩解时间等相关压片及片剂性质,并采用扫描电镜技术对粒子和片剂表面形态进行表征。结果显示,仅加入HPMC的复合粒子的粒径、流动性和抗张强度均优于中药提取物原粉,而加入HPMC和碳酸氢铵的致孔粒子的这些性质得到进一步改善。此外,HPMC的加入会延长片剂的崩解时间,而碳酸氢铵的致孔作用能够在一定程度上对此进行改善。扫描电镜揭示了改性复合粒子形态的变化,以及致孔粒子和所制备的片剂表面存在许多孔洞。综上,将中药提取物与HPMC和碳酸氢铵一起进行流化共处理能够改善中药原粉的粉体学性质和压片及片剂性质,并且具有一定的适用性,为改善一些中药提取物片剂制备性质提供了一个可行的策略。

     

    Abstract: This paper aimed to study the effect of combined co-processing of coating and pore forming on the tableting and tablet properties of traditional Chinese medicine (TCM) extracts together with its applicability. Four TCM extracts were co-processed using fluid bed with hydroxypropyl methyl cellulose (HPMC) as coating agent and ammonium bicarbonate (NH4HCO3) as pore-forming agent. Powder properties (such as particle size and size distribution, bulk density, tap density, moisture content) and tablet properties (including tensile strength, compaction ratio, fast elastic stretch, and disintegration time) were measured and compared among the powders. Scanning electron microscopy (SEM) was applied to characterize the surface of particles and tablets. Results showed that the particle size, flowability, and compactibility of the composite particles with HPMC were superior to the parent powders of TCM extracts. These properties of the porous particles with HPMC and NH4HCO3 showed further improvements. In addition, the addition of HPMC prolonged the disintegration time of tablets, whereas the pore-forming effect of NH4HCO3 could shorten the disintegration time. SEM revealed the changes in the morphology of the composite particles and the pores on the surface of the porous particles and tablets. In conclusion, co-processing with HPMC and NH4HCO3 could improve the powder and tablet properties of TCM extract powders, and this method shows certain applicability, which provides a feasible choice for improving the tableting properties of some TCM extract powders.

     

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