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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 Jin Yin granules, determine the quality standard of the preparation, investigate the stability of the preparation and observe the clinical curative effect. Methods The comprehensive preparation technology was established by decocting and decocting some herbs, spraying and drying, granulating and drying with powdered sugar and bear bile powder. The accelerated stability test and sample retention stability at room temperature were used to observe the granularity of Jinyin granule, Sex, traits and water changes, and the content of chlorogenic acid in the preparation was determined by HPLC to study the stability of the preparation. Results The stability of the drug under high temperature and light conditions was good, and under the conditions of high humidity, the stability, stability and stability of Jinyin Granule properties, moisture and chlorogenic acid content were observed in the sample retention test at 18 months Good; clinical observation experiment, Jin Yin granules total effective rate of 86%. Conclusion Jin Yin Granules within 18 months of good stability, and the efficacy of Ganyingning tablets, Jin Yin granules better effect is an effective drug for the treatment of cholecystitis.