Abstract:
OBJECTIVE To prepare Jinyin Granule and determine its quality control,evaluate its stability and clinical efficacy. METHODS The decoction of a part of herbal was concentrated and spray dried, then mixed with sugar and bear bile to be granulated. Accelerated stability test and room temperature stability test was taken to observe the granule size, dissolution and moisture change, HPLC was used for the determination of chlorogenic acid in Jinyin granules. Clinical therapeutic effect was compared with Danyining tablet. RESULTS The stability of Jinyin granules was good in the conditions of high temperature and strong light, but instability under high humidity, the result of the stability of the properties, moisture and chlorogenic acid of Jinyin granules was good in accelerated test and sample stay at room temperature test in eighteen months. The total effective rate was 86% in clinical observation. CONCLUSION The stability of Jinyin granules was good in eighteen months. Compared with Danyining tablet, Jinyin granules have better therapeutic effect on cholecystitis.