化痔胶囊生产工艺优化和质量研究  

Hemorrhoids Capsule Production Process Optimization and Quality Study

作　　者：马灵珍 

机构地区：[1]亳州职业技术学院药学院,安徽亳州236800

出　　处：《辽宁中医药大学学报》2016年第6期49-54,共6页Journal of Liaoning University of Traditional Chinese Medicine

基　　金：安徽省高等学校教学质量与教学改革工程实训中心建设项目(20101460)

摘　　要：目的：化痔胶囊由槐米、枳壳、茜草、三棱和三七等5味药材组成,其质量状况直接关系到用药的安全性和有效性。方法：采用水提取正交实验法进行化痔胶囊的生产工艺优化;采用高效液相色谱法对化痔胶囊中的大叶茜草素和羟基茜草素进行含量测定,以甲醇-乙腈-0.2%磷酸（35∶50∶15）为流动相,检测波长：250 nm。结果：化痔胶囊的最佳提取工艺为水,10倍量,提取2次,每次1.5 h;显微鉴别和薄层鉴别方法操作简便,准确可靠,重现性好,可用于控制化痔胶囊的质量;大叶茜草素和羟基茜草素分别在0.4218～8.4360μg（r=0.9992）、0.2654～5.3080μg（r=0.9995）进样量与峰面积呈良好的线性关系,平均加样回收率分别为97.07%、98.01%,RSD（n=6）分别为1.86%、1.62%。结论：优选出的制备工艺稳定,适合工业化生产;制定的显微鉴别、薄层鉴别以及高效液相色谱法测定结果准确、灵敏、重复性好。Objective：Hemorrhoids capsule consists of sophora japonica,bitter orange,madder,triangular and notoginseng mixed medicinal material composition and so on,their quality is directly related to drug safety and effectiveness. Methods：the water extract of orthogonal experiment method is adopted to optimize the production process of hemorrhoids capsule;Using high performance liquid chromatography（HPLC）method for the big leaf madder hemorrhoids capsule element and hydroxy madder for content determination,a acetonitrile a 0.2% phosphoric acid with methanol（35∶50∶15）as mobile phase,detection wavelength：250 nm. Results：The optimum extraction technology of hemorrhoids capsule into water,10 times,extracting 2 times,each time 1.5 h;microscopic identification and thin layer identification method is simple,accurate,reliable and reproducible,and can be used to control quality of hemorrhoids capsule;Big leaf madder and hydroxy madder element in 0.4218～8.4360 μg（r = 0.9992）,0.2654～5.3080 μg（r=0.9995）sample had good linear relationship with the peak area,the average sample recovery rate was 97.07%,98.01%,RSD（n=6）were 1.86%,1.62% respectively. Conclusions：Optimizing the preparation process is stable and suitable for industrial production. Set of identification and microscopic identification and thin layer chromatography HPLC determination results are accurate,sensitive and reproducible.

关 键 词：化痔胶囊 制备工艺 质量标准 

分 类 号：R284[医药卫生—中药学]