肛洗二号中药复方熏洗剂的含量测定及其临床应用  

Content Determination and Clinical Application of Gangxi Ⅱ Chinese Medicine Fumigation Agent

作　　者：庞晓晨 成睿珍[1,2] 李玥 赵飞 赵静 

机构地区：[1]天津市滨海新区中医医院药学科,天津300451 [2]天津中医药大学,天津300193

出　　处：《中国中西医结合外科杂志》2017年第5期527-531,共5页Chinese Journal of Surgery of Integrated Traditional and Western Medicine

基　　金：天津市中医药管理局天津市卫生和计划生育委员会中医中西医结合科研课题(2015144)

摘　　要：目的:采用超高效液相色谱(UPLC)方法,建立中药复方熏洗剂中盐酸小檗碱、芦丁和槲皮素含量测定方法,并通过临床应用对照观察,阐明中药复方熏洗剂的临床药用价值。方法:采用ACQUITY UPLC BEH C_(18)(2.1 mm×100 mm,1.7μm)色谱柱;以乙腈-0.1%甲酸为流动相进行梯度洗脱,流速0.3 mL/min,检测波长260 nm,柱温30℃。临床观察根据随机数字表法将患者分为治疗组和对照组,治疗组予以中药洗剂坐浴,对照组予1∶5000高锰酸钾溶液坐浴,疗程2周,观察两组手术后肛缘水肿例数及2周后疗效。结果:盐酸小檗碱、芦丁和槲皮素分别在(5.09~101.80)μg/mL、(10.13~202.60)μg/mL和(5.14~102.80)μg/mL范围内线性关系良好,平均回收率分别为100.73%、100.44%和100.73%(n=6);RSD分别为0.59%、0.89%和0.76%。治疗组水肿160例,对照组为160例,治疗组2周后,治疗组总有效率95.65%,对照组为67.5%(P<0.05)。结论:本实验含量测定方法简便、准确、重现性良好,为中药复方熏洗剂的质量控制提供了理论依据。临床应用研究表明,中药熏洗剂治疗痔疮有效、方便。Objective To establish the method for determination of berberine, rutin and quercetin hydro- chloride concentration in a Chinese herbal compound fumigating lotion using ultra performance liquid chromatog-raphy （UPLC） and to elucidate the clinical value of this fumigating lotion by clinical application and con- trolled observation. Methods The ACQUITY UPLC BEH ClS （2.1 mm × 100 mm, 1.7 μm） column was used and the gradient elution of acetonitrile -0.1% formic acid as mobile phase was carried out with a flow rate of 0.3 mL/min, a detection wavelength of 260 nm and a column temperature of 30 ℃. The clinical observation was divided into the treatment group and the control group according to the random number table method. The treatment group received lotion hip bath and the control group were given 1：5000 potassium permanganate hip bath. After 2 weeks of treatment, the number of anal margin edema after surgery and the therapeutic effect for 2 weeks were observed. Results The calibration curves for berberine hydrochloride, rutin and quercetin were linear in the ranges of （5.09-101.80） μg/mL, （10.13-202.60） μg/mL and （5.14-102.80） μg/mL, respectively and their linearity was good. The average recoveries were 100.73%, 100.44% and 100.73% （n=6）, respectively. RSD were 0.59%, 0.89% and 0.76%, respectively. There were 160 cases of edema in the treatment group and 160 cas- es in the control group. The total effective rate was 95.65% in the treatment group and 67.5% in the control group （P 〈 0.05）. Conclusion The method is simple, accurate and reproducible which provides a theoretical basis for the quality control of traditional Chinese medicine compound fumigants. Clinical application studies suggested that the treatment of hemorrhoids using Chinese herbal medicine fumigation agent was effective and convenient.

关 键 词：中药熏洗剂 混合痔 含量测定 超高效液相色谱法 临床应用 

分 类 号：R285.6[医药卫生—中药学]