复方苦参合剂的稳定性试验研究  

Study on the Stability of Compound Sophorae Mixture

作　　者：谷世平[1] 段雪云[1] 蔡权 李森 范恒[3] GU Shiping;DUAN Xueyun;CAI Quan;LI Sen;FAN Heng(Hubei Provincial Hospital of Traditional Chinese Medicine/Hubei Province Academy of Traditional Chinese Medicine,Wuhan,Hubei 430061,China;The Fifth Hospital of Huangshi City,Huangshi,Hubei 435005,China;Union Hospital of Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430022,China)

机构地区：[1]湖北省中医院/湖北省中医药研究院,湖北武汉430061 [2]湖北省黄石市第五医院,湖北黄石435005 [3]华中科技大学同济医学院附属协和医院,湖北武汉430022

出　　处：《湖南中医药大学学报》2021年第8期1211-1216,共6页Journal of Hunan University of Chinese Medicine

基　　金：国家自然科学基金面上项目(81774093)。

摘　　要：目的研究复方苦参合剂的稳定性。方法采用钠钙玻璃输液瓶包装,在高温(60℃)、高湿(90%±5%)、强光[(4500±500)lx]照射下10 d;在室温自然贮存18个月;于(40±2)℃、相对湿度(75%±5%)条件下贮存6个月,按复方苦参合剂质量标准进行检测;采用观察、口尝法确定其性状;采用pH计测定pH值;比重瓶法测定相对密度;HPLC法测定含量;微生物限度检查法测定微生物限度。结果与0月比较,影响因素试验(0、5、10 d)、加速试验(0、1、2、3、6个月)、长期试验(0、3、6、9、12、18个月)中各时间点,复方苦参合剂的性状、pH值含量、相对密度、微生物限度检查中各项指标均无明显变化(P>0.05),含量变化也在合格范围内。结论复方苦参合剂的有效期暂定12个月,应储存于干燥阴凉处。Objective To study the stability of Compound Sophorae Mixture.Methods Soda-lime glass infusion bottle was used for packaging;high temperature(60℃),high humidity(90%±5%),strong light[(4500±500)lx]for 10 days;natural storage at room temperature for 18 months;at(40±2)℃,relative humidity(75%±5%)for 6 months;and Compound Sophorae Mixture was tested according to the quality standard of Compound Sophorae Mixture;observation,tasting method was used to determine traits;the pH value was determined by a pH meter;relative density was detected through the pyknometer method;HPLC method was used to detect the content;microbial limit test was used to determine microbial limit.Results Compared with 0 month,there were no significant changes(P>0.05)in the indicators of the traits,pH content,relative density and microbial limit inspection in each time point in influencing factor test(0,5,10 d),accelerated test(0,1,2,3,6 months)and long-term test(0,3,6,9,12,18 months),and the content changes were within the qualified range.Conclusion The effective period of the Compound Sophorae Mixture is tentatively 12 months,and it should be stored in a dry and cool place.

关 键 词：复方苦参合剂 稳定性 影响因素试验 加速试验 长期试验 

分 类 号：R285[医药卫生—中药学]