Study on Stability of Qingrejiedu Granules / 中成药

ABSTRACT

Objective: To evaluated the granules stabilities in four conditions by taking the change of Baricalin content and granules surface color as stability test markers. Methods: The content of baicalin was determined by dual wave length iso absortion method and the granules surface color was determined by the diffuse reflectrance spectroscopy. ① The granules were tested in a simulated summer environment (30 ?C , RH92.5%, 1month) and in a high intensity light condition (3000LX, 10dyas). ② The influence of humidity on the stability of the granules was investigated. ③ The expiry date of the granules was predicted by the mutivariate linear regression analysis and compared with the result of the classical constant temperature method. ④ The influences of temperature and humidity on the granules stability were etudied by orthogonal test. Results: ① There was hardly any change in baicalin content of samples in a simulated summer environment and in a high intensity light condition. ② The results showed that the decrease of baicalin content and charge of granules color were obvious when the relative humidity of environment was high and the granules color was more easily influenced by the humidity. ③ The expiry date was about 2.87 years. ④ The results indicated that both temperature and humidity had effects on the change of baicalin content. Conclusion: We tried to estimate the stability of the granules by two indexes. The results showed that Qingrejedu granules was stable in different conditions. It satisfied the stability requirements of solid dosage form.