滑肠通便片的制备、质量控制与临床疗效探讨  

Preparation Quality Control and Clinical Efficacy of Huachangtongbian Tablets

作　　者：张健民[1] 陈小琼[1] 蒋三元[1] 邱国海[1] 

机构地区：[1]江门市新会区中医院,广东江门529100

出　　处：《中国实验方剂学杂志》2010年第6期30-32,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：广东省中医药局2008年资助立项课题(2008063)

摘　　要：目的:探讨滑肠通便片的制备方法、质量控制与临床疗效状况。方法:用薄层色谱法、高效液相色谱法进行制剂中药材定性鉴别和大黄酚的含量测定;用对比的方法观察临床的治疗效果。结果:本制剂制备工艺可行,草决明、大黄薄层色谱斑点明显清晰;大黄酚在413 nm处均有最大吸收,浓度在0.016～0.24μg线性关系良好,相关系数r=0.999 7,平均加样回收率为98.25%(RSD 1.40%,n=6);125例习惯性顽固性便秘患者临床疗效观察,治疗组总有效率为92.0%,明显优于对照组的76.0%。结论:本制剂配方合理、工艺可行,薄层色谱法、高效液相色谱法可有效地控制该制剂内在质量;制剂的临床疗效较好,未见不良反应,值得推广应用。Objective：To discuss the preparation,quality control and clinical efficacy of Huachangtongbian Tablets.Method：The TLC,HPLC were used for the identification and characterization of Chinese herbal medicines preparation and determination of chrysophanol respectively;The antitheses was used in the clinical observation.Result：The preparation technology is feasible.Clear spots were noted in the TLC of Cassia occidentalis and rhubarb;Chrysophanol was linear in the range of 0.016 ～ 0.24 μg（r = 0.999 7） with the maximum absorption at 413nm.The average recovery was 98.25%（RSD 1.40%,n = 6）;125 cases with habitual constipation were used in clinical observation.The total effectiveness in the treatment group was 92.0%,significantly better than 76.0% in the control group.Conclusion：The preparation formula is reasonableand the technology is feasible.TLC and HPLC methods can be used in the quality control of the preparation,with which better clinical efficacy was observed and no adverse reactions occured.

关 键 词：滑肠通便片 制备 质量控制 疗效探讨 

分 类 号：R283.6[医药卫生—中药学] R284.1[医药卫生—中医学]