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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 study the preparation, quality control and clinical curative effect of Hua Chang laxative tablets. Methods: TLC and HPLC were used to qualitatively identify the Chinese herbal medicines and determine the content of chrysophanol. The therapeutic effect was observed by contrast method. Results: The preparation of the preparation was feasible. The chromatographic spots were clear and clear. The maximum absorption of chrysophanol was at 413 nm, the linear range was 0.016 ~ 0.24μg, the correlation coefficient was 0.999 7, the average The recovery rate was 98.25% (RSD 1.40%, n = 6). The clinical efficacy of 125 patients with habitual intractable constipation was 92.0% in the treatment group, which was significantly better than 76.0% in the control group. Conclusion: The formula of the preparation is reasonable and the technology is feasible. TLC and HPLC can effectively control the intrinsic quality of the preparation. The preparation has good clinical curative effect and no adverse reactions, which is worth popularizing and applying.