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目的:根据中医药理论选用党参、甘草、白芍、乌梅、延胡索等中药制成纯天然制剂,治疗萎缩性胃炎。方法:制备工艺为水-醇法并制成冲剂;紫外分光光度法测定总黄酮含量和制剂稳定性考察;将慢性萎缩性胃炎病人127例随机分为2组,以猴菇菌片作为对照,进行了胃灵冲剂的临床疗效观察。结果:制备工艺可行,制剂稳定性良好;含量测定方法可靠,以芦丁为对照,浓度在0~10μg/ml范围内线性关系良好,γ=0.9995;加样回收率达99.61%,SD:1.18%,样品测定结果准确;临床研究显示,治疗组和对照组的总有效率分别为85.9%和50.0%(P<0.01)。结论:胃灵冲剂工艺简便易行,定量方法准确,制剂稳定、安全,对萎缩性胃炎有满意的治疗效果。
Objective: According to the theory of Chinese medicine, the traditional medicines of Codonopsis pilosula, licorice root, white peony, ebony, and yanhusuo were used to make pure natural preparations to treat atrophic gastritis. Methods: The preparation process was water-alcohol method and granules were made; UV spectrophotometry was used to determine the content of total flavonoids and preparation stability; 127 patients with chronic atrophic gastritis were randomly divided into 2 groups. The monkey mushroom tablets were used as controls. The clinical curative effect of Weiling Granules was observed. RESULTS: The preparation process was feasible, the formulation stability was good, and the content determination method was reliable. Taking rutin as a control, the linear relationship was good in the range of 0-10 μg/ml, γ=0.9995; the recovery rate of sample added was 99.61%, SD: 1.18 %, The sample measurement results are accurate; Clinical studies show that the total effective rate of the treatment group and the control group were 85.9% and 50.0%, respectively (P<0.01). Conclusion: The formula of Weiling granules is simple and convenient, the quantitative method is accurate, the preparation is stable and safe, and it has a satisfactory therapeutic effect on atrophic gastritis.