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目的:研制肝宁口服液,制定质量标准,并考察其疗效。方法:根据中医药理论选用清热凉血健脾化湿的中药材,采用水-醇-超滤法的制备工艺制成纯天然制剂。对其进行鉴别,并经药效学、急性毒性试验和临床应用。结果:制剂工艺稳定,各项指标符合质量要求。超滤法用于中药制剂可明显提高药液澄明度。临床观察60例,总有效率为9333%。结论:肝宁口服液对急慢性肝炎有较好辅助治疗作用。
Objective: To develop Ganning oral liquid, establish quality standards, and investigate its efficacy. Methods: According to the theory of traditional Chinese medicine, Chinese herbal medicines with heat, cool blood, spleen, and dampness were selected, and pure natural preparations were prepared using the water-alcohol-ultrafiltration method. It was identified and tested for pharmacodynamics, acute toxicity and clinical application. Result: The formulation process is stable and all indicators meet the quality requirements. Ultrafiltration for traditional Chinese medicine preparations can significantly improve the clarity of the liquid. Clinical observation of 60 cases, the total effective rate was 93 33%. Conclusion: Ganning oral solution has a good adjuvant effect on acute and chronic hepatitis.