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目的:研究探讨中药清热活血胶囊的制备工艺、质量控制标准及临床应用的疗效。方法:首先研究中药清热活血胶囊的制备工艺及质量控制标准,并选择口腔扁平苔藓(简称OLP)的患者72例,按就诊先后顺序用分配卡法随机分为治疗组与对照组各36例,对照组:采用单纯西药治疗,强的松口服3周,第一周30mg/日,第2周15mg/日,第3周5mg/日;磷酸氯喹0.125g/次,每日2次,饭后服;维生素B610mg/次,每日2次;维生素C100mg/次,每日3次;维生素A2.5万u/次,每日3次。治疗组:西药用法同对照组,加用中药清热活血胶囊(主要药物组成:赤芍、川芎、蝉蜕、黄柏、佩兰等)。结果:治疗组取得总有效率为94.44%,对照组为69.44%,两组比较有显著性差异(P<0.05),两组随防复发率比较治疗组随防21例,复发1例;对照组随防12例,复发率3例。结论:中药清热活血胶囊其制备工艺严密、质量控制严格,用于治疗口腔扁平苔藓可取得显著的临床疗效,稳定性强,复发率低。
Objective: To study the preparation of traditional Chinese medicine Qingre Huoxue capsules, quality control standards and clinical effects. Methods: Firstly, the preparation technology and quality control standard of Qingrehuoxue Capsule were studied. 72 patients with oral lichen planus (OLP) were randomly divided into treatment group (36 cases) and control group (36 cases) The control group was treated with western medicine alone, prednisone was given orally for 3 weeks, the first week was 30mg / day, the second week was 15mg / day, the third week was 5mg / day; chloroquine phosphate 0.125g / time, twice a day Service; Vitamin B610mg / time, 2 times a day; Vitamin C100mg / time, 3 times a day; Vitamin A25000 / time, 3 times a day. Treatment group: Western medicine with the control group, plus traditional Chinese medicine Qingre Huoxue capsules (the main drug components: red peony root, Chuanxiong, cicada slough, Treats, Perrin, etc.). Results: The total effective rate was 94.44% in the treatment group and 69.44% in the control group, there was significant difference between the two groups (P <0.05) Group with anti-12 cases, the recurrence rate in 3 cases. Conclusion: The traditional Chinese medicine Qingre Huoxue Capsule has strict preparation technique and strict quality control. It can achieve remarkable clinical curative effect in the treatment of oral lichen planus, with strong stability and low recurrence rate.