降糖灵胶囊的制备与临床疗效观察  

PREPARATION AND CURATIVE EFFECTS OF PHENFORMIN CAPSULES

作　　者：闫芳[1] 李水清[1] 

机构地区：[1]临沂市人民医院,山东临沂276003

出　　处：《山东医学高等专科学校学报》2008年第1期27-30,共4页Journal of Shandong Medical College

基　　金：山东省科技发展计划项目(No.07GG3WZ02039)

摘　　要：目的探讨降糖灵胶囊的制备及治疗2型糖尿病的临床疗效。方法以黄芪甲苷为质量控制指标；以治疗前后降糖灵胶囊治疗为主，饮食及锻炼为辅，1月为1疗程，以治疗前后及1、2、3疗程检测血糖进行综合评价。结果降糖灵胶囊中所含黄芪甲苷不少于0．285mg／g；降糖灵胶囊急性毒性实验报告显示，小白鼠灌胃降糖灵胶囊1d最大耐受量为216g／kg，按公斤体重计算，该剂量为临床常用量的288倍，观察7d未见任何毒性反应。降糖灵胶囊服用简便、易行、实用性强。采用降糖灵胶囊治疗的86例2型糖尿病患者的治疗结果表明：治疗1～3个疗程平均血糖分别由治疗前的（12．48±2．16）mmol／L降至（11、12±2．07）mmol／L、（9．86±2．30）mmol／L和（6．31±2．28）mmol／L；第1疗程血糖测定结果与治疗前比较无显著性差异（P〉0．05），第2、3疗程与治疗前比较有显著性差异（P〈0．05或P〈0．01）。治疗3个疗程后的总有效率为87．21％。结论降糖灵胶囊组方合理，制备工艺可行，质量标准可靠，疗效确切，未见不良反应。Objective To explore the preparation and curative effects of phenformin capsules in treating Type Ⅱ diabetes. Methods The level of astragaloside was used as the index of quality control. Phenformin capsules were mainly used in the treatments and diet therapy and exercise were used as auxiliary ways. The curative effects were determined after the first, second and third courses of treatment. Results The content of astragaloside in the capsule should not be less than 0. 285mg/g. The acute toxicity experiment shoved that the maximum tolerance dosage of a mouse a day was 216g/kg,which was 288 times that of clinical dosage. 7 clays of observation revealed no toxicity reactions. 86 cases of Type Ⅱ diabetes were treated with the drug. The levels of blood glucose decreased from（12.48 ± 2.16）mmol/L to （11.12 ± 2.07） mmol/L, and （9.86 ± 2.30）mmol/L and （6.31 ± 2. 28） mmol/L after three courses of treatment respectively, singnificant dicflerences existed before and after the second and third courses of treatment, （ P 〈0.05 or P 〈0.01） but no significant diffences were found before and after the first course of treatment （ P 〉0.05）. The total effective rate after three courses of treatment was 87. 21%. Conclusion The preparattion has proved to reasonable and feasible and phenformin capsules can produce good curative effects without side effects.

关 键 词：降糖灵胶囊 黄芪甲苷 2型糖尿病 血糖 临床疗效 

分 类 号：R286[医药卫生—中药学]