首页|小建中合剂活性炭除杂工艺优化及其制剂稳定性影响研究

小建中合剂活性炭除杂工艺优化及其制剂稳定性影响研究

扫码查看
为提高小建中合剂制剂澄清度与稳定性,选用活性炭除杂工艺纯化小建中合剂,采用正交试验评价法,以活性炭的用量、煮炭时间、除炭时的药液温度为考察因素,以芍药苷转移率、干物质转移率为考察指标,进行方差分析、直观分析结合加速稳定性试验结果,优选小建中合剂活性炭除杂工艺,并在该条件下生产 3 批小建中合剂制剂进行长期稳定性试验。结果表明小建中合剂制剂煮炭除杂最佳工艺参数为活性炭使用量 0。4%、煮炭时间 30 min及滤过时药液温度 100℃,此工艺条件扩大生产的平均芍药苷转移率为 75。24%、干物质转移率为 89。08%。该试验所得最佳煮炭除杂工艺可保证小建中合剂澄清度及稳定性,同时最大程度保留芍药苷及干物质,从而保证药品疗效的稳定均一,为小建中合剂煮炭除杂纯化工艺参数的明确及优化提供了科学、合理的依据。
Optimization of activated charcoal impurity removal process for Xiaojianzhong mixture and its impacton the stability of the mixture's preparations
To improve the clarity and stability of Xiaojianzhong mixture,the activated charcoal impurity removal process was selected to purify Xiaojianzhong mixture.The orthogonal test evaluation method was used;the evaluation factors were the amount of activated charcoal,boiling time,and the temperature of the solution during charcoal removal.Furthermore,the transfer rates of paeoniflorin and dry matter were used as evaluation indicators.Variance and visual analyses as well as accelerated stability tests were conducted to optimize the activated charcoal purification process for Xiaojianzhong mixture.In order to carry out these above experiments,three batches of Xiaojianzhong mixture preparations were produced for long-term stability testing.Results showed that the optimal parameters for the activated charcoal boiling purification process of Xiaojianzhong mixture preparations were 0.4%activated charcoal usage,30 min of activated charcoal boiling time,and a liquid temperature of 100℃ during filtration.The average transfer rates of paeoniflorin and dry matter in expanded production under these process conditions were 75.24%and 89.08%,respectively.The optimal activated charcoal boiling purification process obtained from this test can ensure the clarity and stability of Xiaojianzhong mixture preparations while maximizing the retention of paeoniflorin and dry matter,thereby ensuring stable and uniform drug efficacy.This study provides a scientific and reasonable basis forclarifying and optimizing the parameters of the activated charcoal boiling purification process for Xiaojianzhong mixture.

Xiaojianzhong mixtureactivated charcoalHPLCpaeoniflorindry matter

张微、刘震远、杜昊忱、郭田甜、杨梅、王善栋、韩培、宋祥云、张贵民

展开 >

鲁南厚普制药有限公司 中药制药共性技术山东省工程研究中心,山东 临沂 276006

鲁南制药集团股份有限公司 经方与现代中药融合创新全国重点实验室,山东 临沂 276006

鲁南制药集团股份有限公司,山东 临沂 276006

小建中合剂 活性炭 高效液相色谱 芍药苷 干物质

山东省重点研发计划项目山东省新旧动能转换重大产业攻关项目

2021CXGC010508鲁动能办[2021]23号

2024

山东科学
山东省科学院

山东科学

CSTPCD
影响因子:0.266
ISSN:1002-4026
年,卷(期):2024.37(4)