滑肠通便片的制备、质量控制和临床疗效探讨.docVIP

PAGE PAGE 3 滑肠通便片的制备、质量控制与临床疗效探讨 张健民[基金项目] 广东省中医药局2008年资助立项课题（编号2008063） [基金项目] 广东省中医药局2008年资助立项课题（编号2008063） [通讯作者] *张健民，Tel：（0750）6621124，E－mail:6191861jm@163.com （江门市新会区中医院，广东　江门 529100） 【摘要】　目的：探讨滑肠通便片的的制备方法、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413nm处均有最大吸收，浓度在0.016～0.24μg范围内线性关系良好，相关系数r＝0.9997，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。 【关键词】滑肠通便片；制备；质量控制；疗效探讨 Preparation、Quality control and Clinical efficacy of Huachangtongbian tablets ZHANG Jian-min＊，CHEN Xiao-qiong，JIANG San-yuan，QIU Hai-guo （Xinhui Hospital of Chinese medicine，Jiangmen　Guangdong，529100） 【Abstract】Objective： To discuss the preparation、quality control and clinical efficacy of Huachangtongbian tablets . Methods: The TLC, HPLC were used for the identification and characterization of Chinese herbal medicines preparation and Determination of chrysophanol;The antitheses was used in observed the clinical effectiveness. Results: The preparation technology is feasible, Cassia occidentalis、rhubarb clear spots were noted in their TLC; rhubarb phenols have maximum absorption at 413nm, a good linear relationship was achieved over the concentration range of 0.016～0.24μg ( r = 0.9997), the average recovery rate was 98.25% (RSD=1.40%，n=6); 125 case with habitual constipation were used in clinical observation, the total effective in the rate treatment group was 92.0%, significantly better than the control group 76.0%.Conclusion: The preparation formula is reasonable、 technology is feasible, TLC、HPLC method can control the inherent quality of the preparation effectively; the preparation with better clinical efficacy, no adverse reactions, should be widely used.【Key words】 Huachangtongbian tablets; preparation; quality control; investigate the efficacy 滑肠通便片是我院临床专科应用的制剂，由草决明、大黄等中药制成，具有润肠通便、活血化瘀之功效。临床上用于大便秘结，慢性结肠炎等疾病治疗，使用多年，虽