动物类中药材稳定性研究中适宜条件的选择-以水蛭、地龙为例

Selection of suitable conditions in the stability study of animal Chinese medicinal materials：takinghirudoesand pheretimasas examples

关键词:  动物类中药材  稳定性试验  水蛭  地龙

Key words:  animal traditional Chinese medicine  stability test  hirudo  pheretima

摘要:

[目的] 对水蛭、地龙进行稳定性试验，考察其在设定条件下出现的质量波动和变化情况，为合理评估动物类中药材的贮藏条件提供参考，为该类药材选择适宜条件开展稳定性研究提供重要实验依据。[方法] 参照稳定性指导原则，对不同批次的水蛭、地龙进行影响因素试验、（30±2）℃、相对湿度（RH）为（65±5）%条件下的加速试验，及低温条件（6±2）℃、低湿条件[（25±2）℃，RH（40±5）%]下9个月的长期试验，测定相应检查项目。[结果] 在影响因素、加速、长期试验中，三批水蛭、地龙药材检查项目均符合质量标准要求。[结论] 水蛭、地龙可以采用在[（30±2）℃，RH（65±5）%]的加速试验条件以及低温条件[（6±2）℃]、低湿条件[（25±2）℃，RH（40±5）%]的长期试验条件下开展稳定性试验，也可作为其他动物类中药材相关质量研究和稳定性研究的重要参考。

Abstract:

[Objective] The stability tests of hirudoes and pheretimas were carried out to investigate the quality fluctuation and change of hirudoes and pheretimas under the set conditions,so as to provide a reference for the reasonable evaluation of the storage conditions of animal traditional Chinese medicine and provide an important experimental basis for the selection of appropriate conditions for the stability study of this kind of medicine.[Methods] With reference to the stability guidelines,carry out influential factor tests on different batches of hirudoes and pheretimas,accelerated tests under conditions of[(30±2)℃,RH(65±5)%],and low temperature conditions[(6±2)℃],nine months long-term test under low humidity conditions[(25±2)℃,RH (40±5)%],and the corresponding inspection items were determined.[Results] In the influencing factors,acceleration and long-term experiments,the stability of the three batches ofhirudoesandpheretimas medicine met the quality standards.[Conclusion] Hirudoes andpheretimascan be used for stability test under accelerated test conditions of (30±2)℃,RH (65±5)% and long-term test conditions of low temperature[(6±2)℃] and low humidity[(25±2)℃,RH (40±5)%],which can also be used as an important reference for quality and stability research of other animal Chinese medicinal materials.