金茵颗粒剂的制备及临床应用

Preparation and Clinical Application of Jinyin Granules

目的制备金茵颗粒剂,确定该制剂质量标准,考察该制剂的稳定性,观察临床疗效。方法采用部分药材水煎浓缩、喷雾干燥后,与糖粉、熊胆粉混合制粒,干燥的综合制备工艺;采用加速稳定性试验和室温留样稳定性试验,观察金茵颗粒剂粒度、溶化性、性状和水分变化,并用HPLC测定制剂中绿原酸含量,从而研究该制剂稳定性,与胆益宁片对比观察临床疗效。结果在高温、强光条件下药物稳定性较好,在高湿条件下不稳定,加速试验与18个月室温留样试验中金茵颗粒剂性状、水分及绿原酸含量测定结果显示稳定性好;临床观察实验中,金茵颗粒剂总有效率为86%。结论金茵颗粒剂在18个月内稳定性较好,与胆益宁片疗效比较,金茵颗粒剂疗效较好,是治疗胆囊炎的有效药物。

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.