清痤片的制备及临床疗效观察

The Preparation and Clinical Application of Qingcuo Tablets

目的建立清痤片的制备及质量控制方法,并观察其临床疗效。方法按照处方工艺制备清痤片;建立性状、鉴别、检查等质量标准;设治疗组、对照组观察疗效。结果片剂质量符合《中国药典》要求;治疗组153例,甘草锌颗粒对照组149例,维胺酯胶囊对照组142例,总有效率分别为90.8%、81.9%和95.1%,治疗组与甘草锌颗粒对照组均未发现明显的不良反应,维胺酯胶囊对照组发生不良反应26例,占18.3%。结论清痤片制备方法合理,方中主药质量可以控制,临床上对痤疮有明显的疗效,未发现明显不良反应。

Objective To prepare the Qingcuo Tablets and observe the clinical efficacy on acne.Methods The Qingcuo Tablets were prepared and the identification was performed by TLC.A total of 444 patients with acne were randomly divided into one treatment group and two control groups to observe the clinical effect.153 cases in the treatment group were administered with Qincuo Tablets for 6 weeks,and 149 cases in control group Ⅰ were administered with Licorice zinc particles for 6 weeks,and 142 cases in control group Ⅱ were administered with Viaminati Capsules for 6 weeks.Results The quality of the tablets reached to the standard of China Pharmacopoeia.The effective rates of the treatment group,the control group Ⅰ and the control group Ⅱ on acne were 90.8%,81.9% and 95.1%,respectively.No obvious adverse reactions were found in treatment group and control group Ⅰ,while 26 cases of adverse reactions were found after treatment with Viaminati Capsules,accounting for 18.3%.Conclusion This preparation is stable in quality and feasible in quality control,which has good effects on acne with no obvious adverse reactions.