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目的：对复方愈肝胶囊的制备及质量控制标准进行研究，并初步考察本制剂的临床疗效。方法：用显微特征和薄层色谱的方法对处方药物和主要有效成分齐墩果酸和獐牙菜苦苷进行定性鉴别，并通过给药前后对照考察其临床疗效。结果：本制剂工艺稳定，显微鉴别特征性强，薄层色谱能得到有效分离，专属性强，重现性好。结论：复方愈肝胶囊对慢性乙型肝炎病人改善临床症状，恢复肝功能，阻止乙肝病毒复制，促进乙肝病毒清除具有较好作用。
OBJECTIVE: To study the preparation and quality control standards of compound Yugan Capsules and to investigate the clinical efficacy of the preparations. METHODS: The prescription drugs and main active ingredients oleanolic acid and swertiamarin were qualitatively identified by microscopic features and thin-layer chromatography. The clinical efficacy of the prescription drugs before and after administration was examined. RESULTS: The preparation process was stable, and the characteristics of microscopic identification were strong. Thin-layer chromatography could be effectively separated, with strong specificity and good reproducibility. Conclusion: Compound Yugan capsule has a good effect on chronic hepatitis B patients to improve clinical symptoms, restore liver function, prevent the replication of hepatitis B virus, and promote the elimination of hepatitis B virus.