中药固体制剂防潮技术与辅料应用的研究

目的:研究制剂技术和辅料应用在改善中药固体制剂防潮水平方面的作用与规律。方法:通过分析中药固体制剂吸湿的过程及其机理,提出了一个“吸湿位”的概念,并建立描述吸湿过程的数学模型,从而引入两个描述制剂吸湿过程的难易程度的参数:初始吸湿位浓度C0和阻湿速率参数K。以刺五加浸膏和双黄连浸膏为例,通过改变制剂处方的初始吸湿位浓度、改变吸湿位的空间分布和包薄膜衣等增加水分传质阻力的方法,实验测定了它们在提高制剂防潮水平方面的作用。结果:减少处方中引湿性辅料的应用和包薄膜衣可以降低制剂的引湿性和减慢吸湿速度。结论:数学模型的建立为开展改善中药固体制剂防潮水平的研究提供了一个适用的工具;实验数据表明,降低处方中引湿性辅料的应用和通过一定的制剂技术如薄膜包衣技术增加水分传递阻力,可以提高制剂的防潮能力。

Effectiveness of dosing technology and coating material excipient's application on solid drug's moisture-proof improvement

AIM: To investigate the effectiveness of dosing technology and excipient application on solid drug's moisture-proof property and to provide a method improving the solid drug's moisture-proof property. METHODS: Based on the analysis of the moisture absorbing process and the absorbing mechanics,a new concept "active moisture absorbance site"(AMAS) was defined and mathematic model was constituted.Two constants as: initial AMAS concentration C_0,moisture resistance coemcient K,were proposed to indicate the drugs moisture-proof ability. The CI WU JIA extracts and SHUANG HUANG LIAN extracts were used to conduct experiments, which were designed to investigate the improvement of the drug's moisture resistance ability when varying the AMAS's concentration and/or its space distribution. RESULTS: Reducing the amount of moisture absorbance excipients in each dosage of solid drug can lower the drug's moisture absorbance ability,and applying a thin film coating material outside the drug can also slow the drug's moisture absorbance rate. CONCLUSION: The proposed mathematic model is useful for finding a way to improve the drug's moisture resistance;experimental data shows that the drug's moisture-proof property would be improved by reducing the amount of moisture absorbance excipient in each dosage and improving the moisture distribution resistance through a certain dosing technology,such as film coating technology.