参山颗粒原料和成品的吸湿性比较研究  

Comparative Study on the Hygroscopicity of the Raw Material and Finished Products of Shenshan Granules

作　　者：蒋星 刘平安[1,2,3,4] 田慧 陈芳 陈光宇[1,2,3,4] 谢梦洲 Jiang Xing;Liu Ping’an;Tian Hui;Chen Fang;Chen Guangyu;Xie Mengzhou(Hunan University of Chinese Medicine,Changsha 410208,China;Hunan University of Chinese Medicine,Hunan Engineering Technology Research Center for Medicinal and Functional Food;Hunan University of Chinese Medicine,Provincial Key Laboratory for TCM Diagnostics of Hunan;Hunan University of Chinese Medicine,Key Laboratory for Cardiopulmonary Disease Syndrome Differentiation and Medicinal Diet Therapy of Chinese Medicine)

机构地区：[1]湖南中医药大学,长沙410208 [2]湖南省药食同源功能性食品工程技术研究中心 [3]中医诊断学湖南省重点试验室 [4]湖南中医药大学中医心肺病证辨证与药膳食疗重点研究室

出　　处：《中国药师》2022年第8期1328-1333,共6页China Pharmacist

基　　金：湖南省重点研发计划项目(编号:2022SK2018);湖南省教育厅研究生创新项目(编号:CX20210707);湖南省药食同源工程中心开放基金(2018YSTY07)。

摘　　要：目的:筛选防潮性最优的辅料和干法制粒最优参数,确定参山颗粒制剂生产各道工序的相对湿度条件及该湿度下的最长操作时间,为工业化生产提供依据。方法:测定不同湿度环境溶液中参山颗粒原料与成品的吸湿百分率,建立数学模型,并求算其临界相对湿度(CRH),以及在此相对湿度条件下的最长操作时间。结果:制剂处方配比为原料10.0 g、麦芽糊精6.5 g、二氧化硅1.5 g可显著降低原料的吸湿性(P<0.05);成品最优工艺参数为压轮转速8.0 r·min^(-1),压轮压力6 MPa,送料速度25 r·min^(-1),整粒速度40 r·min^(-1);原料和成品CRH分别为53.34%,68.26%;最长操作时间分别为2.075,4.573 h,可保证参山颗粒吸水量低于8%。结论:本试验结果可为制剂处方防潮辅料筛选和工业化生产过程中原料与成品的操作环境的湿度条件和操作的最长时间提供依据和参考。Objective: To screen excipients with the best moisture resistance and the optimal parameters of dry granulation, and to determine the relative humidity condition for each process in the production of Shenshan granules and the longest operating time under the humidity condition, so as to provide basis for industrial production.Methods: The moisture absorption percentage of raw materials and finished products of Sanshan granules in solutions with different humidity environment was determined, a mathematical model was established, and the critical relative humidity(CRH) and the longest operating time under this relative humidity condition were calculated. Results: The formulation of raw material 10.0 g, maltodextrin 6.5 g and silicon dioxide 1.5 g could significantly reduce the hygroscopicity of the raw material(P<0.05);the optimum process parameters of the finished products were as follows: the roller speed was 8.0 r·min^(-1), the pressure of the pressing wheel was 6 MPa, the feeding speed was 25 r·min^(-1), and the granulation speed was 40 r·min^(-1);the CRH of raw materials and finished products was 53.34% and 68.26%, respectively;the longest operating time was 2.075 and 4.573 hours, respectively, which could guarantee the water absorption of Shenshan granules lower than 8%. Conclusion: The results of this experiment provide basis and reference for the selection of moisture-proof excipients in formulation, humidity conditions and maximum operating time of raw materials and finished products in the process of industrial production.

关 键 词：参山颗粒 原料 成品 辅料 吸湿性 临界相对湿度 

分 类 号：R283.62[医药卫生—中药学]