小包装中药饮片葛根质量稳定性研究

Quality stability of small package of Chinese medicine pieces of Puerariae lobatae Radix

目的考察小包装中药饮片葛根的质量稳定性。方法用2015年版《中国药典》葛根的检测方法,先进行影响因素(高温、高湿、强光照射)试验的考察,再采用加速试验和长期试验考察其质量稳定性。结果高温60℃条件:样品性状变化明显;高湿RH 92.5%条件:水分增大明显;强光照无明显变化。小包装中药饮片葛根在温度40℃、RH 75%条件下在第3个月取样时发现霉变,在温度30℃、RH 65%条件下储存时间可超过3个月;小包装中药饮片在温度25℃,RH 60℃条件下可储存12个月以上。结论该研究可为小包装中药饮片葛根的保存条件和有效期提供依据。

Objective To investigate the quality stability of small package of Chinese medicine pieces of Pueraria lobata Radix. Methods According to the content detection method Chinese Pharmacopoeia （2015 edition）, the different factors （high temperature, high humidity and strong light） were analyzed firstly, and then the accelerated experiment and long-term experiment were used to investigate its quality stability. Results Under the condition of 60 , sample characters were changed obviously, und℃ er the condition of RH 92.5%, water content was significantly increased, and there were no significant changes under strong light. Under the conditions of 40 and℃RH 75%, the small package of Chinese medicine pieces of Puerariae lobatae Radix occurred mildew and rot after 2-3 months. Under the conditions of 30 and RH 65%, the small package of Chinese medicine pieces of℃ Puerariae lobatae Radix was valid for 3 months. Under the conditions of 25 and RH 60%, the small package of Chinese℃medicine pieces of Puerariae lobatae Radix could be stored for more than 12 months .Conclusion The study can provide the basis for the preservation conditions and validity period of small package of Chinese medicine of Puerariae lobatae Radix.