复方芍红颗粒的稳定性研究  

Study of stability of Fufangshaohong Granules

作　　者：陈金凤[1] 杨东亮[1] 朱青梅[1] 滕亮[1] CHEN Jinfeng YANG Dongliang ZHU Qingmei TENG Liang(Pharmacy Division, the First Affiliated Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region, Urumqi 830011, China)

机构地区：[1]新疆医科大学第一附属医院药学部,新疆乌鲁木齐830011

出　　处：《中国医药导报》2017年第6期151-155,共5页China Medical Herald

摘　　要：目的为复方芍红颗粒的贮存条件及有效期的制订提供参考。方法采用影响因素试验,高温(60、40℃),高湿[RH(90±5)%、(75±5)%],光照[照度(4500±500)lx]等条件探测影响该制剂的因素,加速试验[温度(40±2)℃、湿度(75±5)%;温度(30±2)℃,湿度(60±5)%]加速其有效成分的降解,经典恒温试验(在50~80℃4个不同温度恒温水浴锅条件下,定时取样,测定溶液中芍药苷的残余浓度)初步预测其有效期。结果影响因素试验结果表明复方芍红颗粒对光线较为稳定,但高温高湿条件下芍药苷含量均有明显下降,提示在贮存过程中应注意控制环境的湿度与温度,应于阴凉干燥处存放,通过经典恒温法预测该颗粒剂有效期为1.48年。结论本文建立了可用于控制复方芍红颗粒质量稳定的储存条件,采用复合膜密闭包装且低温干燥处存放,可以提高该制剂的稳定性。本实验精密度高、重复性好、可信度高,所得数据可为复方芍红颗粒最终的贮存条件及有效期的制订提供参考。Objective To provide storage conditions for Fufangshaohong Granules and provide reference for the establishment of the period of validity. Methods Factors affecting test, high temperature （60% and 40℃）, high humidity [RH （90±5）%, （75±5）%], light [（4500±500） lx] illumination condition such as detection of the influencing factors of the prepa- ration, accelerated test： temperature （40±2）℃, humidity （75±5）%, temperature （30±2）%, humidity （60±5）% to accelerate the degradation of its effective components, classical constant temperature experiment （50-80℃ in four different temperature under the condition of constant temperature water-bath water, regular sampling, determination of the residual concentrations of paeoniflorin in solution） preliminary forecast its validity. Results Factors affecting the test results showed that the Fufangshaohong Granules relatively stable to light, but under the condition of high temperature and high humidity paeoniflorin content were significantly decreased, environment should be paid attention to in the process of storage control of humidity and temperature, deposit should be in a cool and dry place, through classical constant temperature method to predict the validity of the granules of 1.48 years. Conclusion This paper establishes the Fufangshaohong Granules can be used to control the quality stability of the storage conditions, the composite film sealed packaging and dry storage at low temperature, can improve the stability of the preparation. This experiment high precision, good repeatability, high reliability, the data can be stored for Fufangshaohong Granules eventually conditions and provide reference for the establishment of the period of validity.

关 键 词：复方芍红颗粒 影响因素试验 加速试验 经典恒温试验 

分 类 号：R917[医药卫生—药物分析学]