血塞通滴丸整合溶出度测定方法的建立  

Determination method for the integrated dissolution of Xuesaitong dropping pills

作　　者：闫伟伟 罗慧玉 唐殿飞 丁杰 陈正源 YAN Wei-wei;LUO Hui-yu;TANG Dian-fei;DING Jie;CHEN Zheng-yuan(Zhangjiakou Food and Drug Inspection Center,Zhangjiakou Hebei 075000)

机构地区：[1]张家口市食品药品检验中心,河北张家口075000

出　　处：《中南药学》2022年第2期261-265,共5页Central South Pharmacy

基　　金：张家口市重点研发计划项目(No.2021027D)。

摘　　要：目的建立基于质量分数权重系数法的血塞通滴丸整合溶出度检验方法。方法参照《中国药典》2020年版四部溶出度测定法第三法(小杯法);采用高效液相色谱法测定不同时间点血塞通滴丸中三七皂苷R_(1)、人参皂苷Rg_(1)、人参皂苷Re、人参皂苷Rb_(1)、人参皂苷Rd5种指标成分的溶出度,以质量分数加权后计算整合溶出度;对整合溶出度进行相似分析及模型拟合,计算溶出参数T_(50),T_(d),T_(85)。结果采用试验确定的溶出条件,15 min时血塞通滴丸整合溶出度均大于85%。整合溶出度与5种指标成分溶出曲线均相似(f_(2)>50)。溶出模型以Weibull模型最好,溶出参数T_(50),T_(d),T_(85)分别为3.87 min、5.19 min、12.33 min。结论该溶出度检查方法准确可靠、方法简便;以质量分数加权后的整合溶出度能较好地表征血塞通滴丸的体外溶出行为。Objective To establish an integrated dissolution test method for Xuesaitong dropping pills based on weight coefficient of the mass fraction.Methods According to the small cup method in Chinese Pharmacopoeia(2020 Edition),the dissolution of notoginsenoside R_(1),ginsenoside Rg_(1),ginsenoside Re,ginsenoside Rb_(1) and ginsenoside Rd in Xuesaitong dropping pills at different time points was determined by HPLC.The integrated dissolution was calculated by weight of mass fraction.Similarity analysis and model fitting were conducted for the integrated dissolution.The dissolution parameters T_(50),T_(d),and T_(85) were calculated.Results The dissolution of Xuesaitong dropping pills was more than 85% after 15 min under the experimental conditions.The integration dissolution curves were similar to those of the 5 indexes(f_(2)>50).Weibull model was the best model for the dissolution test.The dissolution parameters T_(50),T_(d) and T_(85) were 3.87 min,5.19 min and 12.33 min,respectively.Conclusion The dissolution test method is accurate,reliable and simple.The dissolution behavior of Xuesaitong dropping pills in vitro are well characterized by the integrated dissolution weighted by the mass fraction.

关 键 词：血塞通滴丸 整合溶出度 溶出曲线 相似因子 

分 类 号：R94[医药卫生—药剂学]