今日药学

2020, v.30(10) 694-698

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丹参破壁饮片与破壁粉的稳定性比较研究
Comparative Study on the Stability of Salvia Miltiorrhiza Ultrafine Granular Powder and Ultrafine Powder

张前亮;邓雯;罗铮;刘星云;成金乐;
ZHANG Qianliang;DENG Wen;LUO Zheng;LIU Xingyun;CHENG Jinle;Key Laboratory of Technologies and Applications of Ultrafine Granular Powder of Herbal Medicine,State Administration of Traditional Chinese Medicine;Zhongshan Zhongzhi Pharmaceutical Group Co.Ltd.;

摘要(Abstract):

目的比较丹参破壁饮片与破壁粉的稳定性差异,为丹参饮片创新开发和剂型选择提供依据。方法采用影响因素和加速稳定性试验,依据2015年版中国药典中丹参的水分、指标成分含量测定方法开展稳定性考察。结果在高温、高湿、光照条件下,丹酚酸B含量下降,丹参破壁粉相较破壁饮片下降幅度更大。丹参酮类含量二者均有小幅下降,下降率差异无统计学意义。加速试验中2种饮片指标性成分的含量变化规律同影响因素试验一致,丹参破壁饮片4种指标性成分的综合变化率小于破壁粉,差异有统计学意义。结论丹参的指标性成分对高温、高湿、光照都较敏感,受其影响含量下降,但丹参破壁饮片较破壁粉稳定。
OBJECTIVE Comparison of stability differences between ultrafine granular powder and ultrafine powder which were made from traditional pieces of Salvia miltiorrhiza Bunge,providing evidence for the development and formulation application of Salvia miltiorrhiza pieces. METHODS Using the influence factors and accelerated stability test,the active ingredient( total tanshinone and salvianolic acid) in two formulations were determined by HPLC and the content of water was detected by the method from Chinese Pharmacopoeia( 2015 Edition). RESULTS Under the conditions of high temperature,high humidity and illumination,the content of salvianolic acid B was decreased,and the content of salvianolic acid B in the ultrafine powder was decreased faster than that in the ultrafine granular powder. Also,the content of tanshinone in two formulations were slightly decreased,and there are no significant difference in decline rate. In the accelerated test,changes rules of the contents in the active component content of the two formulations were the same as that of the influencing factor test,and the comprehensive change rate of the four components of Salvia miltiorrhiza ultrafine granular powder were significantly smaller than that of the ultrafine powder. CONCLUSION The active components of Salvia miltiorrhiza are sensitive to high temperature,high humidity,and light,which can make the contents of Salvia miltiorrhiza decrease However,under these three factors,the contents in the ultrafine granular powder are more stable than that in the ultrafine powder.

关键词(KeyWords): 丹参;破壁饮片;比表面积;稳定性;含量测定
Salvia miltiorrhiza;ultrafine granular powder;specific surface area;stability;content determination

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基金项目(Foundation): 广东省省级科技计划项目(2018B0202072008);; 广东省中药破壁饮片工程实验室(粤发改创新函[2018]3149号);; 中山市协同创新中心建设(2016C1014)

作者(Author): 张前亮;邓雯;罗铮;刘星云;成金乐;
ZHANG Qianliang;DENG Wen;LUO Zheng;LIU Xingyun;CHENG Jinle;Key Laboratory of Technologies and Applications of Ultrafine Granular Powder of Herbal Medicine,State Administration of Traditional Chinese Medicine;Zhongshan Zhongzhi Pharmaceutical Group Co.Ltd.;

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