摘要
目的探讨甘露退热颗粒的制备工艺、质量标准,以有效控制甘露退热颗粒的质量,使甘露退热颗粒达到新制剂报备水平。方法以甘露退热颗粒的浸膏得率、钙离子提取量、后下药粉碎度等为考察指标,不同的煎煮时间、加水量、煎煮次数等条件,用正交法试验进行统计评价,分别研究先煎药、后下药、共煎药的最佳提取工艺;并用薄层色谱作为鉴别方法。结果甘露退热颗粒的最佳提取工艺为先煎药加14倍水提取2次每次1 h后与共煎药定量至12倍水,提取2次,每次90 min。后下药粉碎后过10目筛加8倍水煮6 h提取挥发油。黄芩、土茯苓进行薄层色谱法鉴别是切实可行的。结论本文设计的甘露退热颗粒的制备工艺及质量标准准确可靠,可用于建立甘露退热颗粒的质量标准。
Objectives To explore the preparation process and specifications of Ganlu Tuire Granules to control effectively the quality of the Granules,which is enabled to satisfy the archival filing requirements for new drug product.Methods Yield of extract,Ganlu Tuire Granules extraction rate with calcium ion chelating agent and comminution degree of drugs to be decocted later acted as the evaluation indices and different decoction time,the amount of water to be added and decoction frequency as condition variables and the statistical analysis was made with orthogonal experimental method to find the optimal extraction process for decoctions with some drugs to be decocted first,some drugs to be decocted later and drugs to be decocted at the same time;thin layer chromatography served as the identification method.Results Optimal extraction process Ganlu Tuire Granules for the decoction with some drugs to be detected first was to add the amount of water which was 14 folds of the amount of the water used to decoct and the number of times of extraction is two with 1 hour of extracting time per time;for the decoction with drugs to be decocted at the same time was to add water to the amount which was 12 folds of the amount of the water used to decoct to extract two times with 90 min of extracting time per time.For the decoction with drugs to be detected later,the optimal process was that after comminution,the decoction with drugs to be decocted later was sifted with 10 mesh and then boiled for 6 hours with the amount of water added which is 8 folds of the amount of the water used to decoct and volatile oil was extracted.The identification of baical skullcap root and glabrous greenbrier rhizome with thin layer chromatography is feasible.Conclusion Preparation process and specifications of Ganlu Tuire Granules in this article can be applied to the constitution of the specifications of Ganlu Tuire Granules,the design of which was accurate and reliable.
作者
谢锴标
陈震尧
彭矿薇
邓礼荷
邱新华
XIE Kai-Biao;CHEN Zhen-Yao;PENG Kuang-Wei;DENG Li-He;QIU Xin-Hua(Department of Pharmacy,Zhaoqing Hospital of Traditional Chinese Medicine,Zhaoqing 526020,China;Department of Pharmacy,Zhaoqing Medicine College,Zhaoqing 526020,Chin)
出处
《中国药物经济学》
2023年第4期88-92,共5页
China Journal of Pharmaceutical Economics
基金
广东省肇庆市科技创新指导类项目(201904031105)。
关键词
甘露退热颗粒
制备工艺
钙离子
薄层鉴别
Ganlu tuire granules
Preparation process
Calcium ion
Thin layer chromatography identification
