胃灵冲剂的研制及临床疗效观察

The Preparation of Weiling Granules and Its Therapeutic Effects

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 traditional Chinese medical and medicinal theory,a purely natural pharmaceutical preparation,mainly for treating atrophic gastritis,was made through selecting use of Radix Codonopsis,Radix Glycyrrhizae,Radix Paeoniae,Fructus Mume,Rhizoma Corydalis etc.METHODS:Water extracting and alcohol depositing technique were adopted to make granules.By imitating the determintion of rutine,UV spectrophotometry was used to determine the content of total flavones which are the effective components in Weding Granules and to investigate the stability of the preparation.One hundred and twenty-seven patients were randomly divided into 2 groups,85 patients(M53,F32,age 4918y) were treated with Weding Granules 20g,po,tid for 90d and another 42 patients (M27,F15,age 471±9y) were treated with Hougujun tablet 3g,po,tid for 90d as control.RESULTS:Preparation technique and stability were proved to be satisfactory.Taking rutine as control,the linear ranges of ient. The preparation was stable and safe.The method of content determination was reliable.The effect on treating atrophic gastritis was satisfactory.