连番止泻微丸制剂工艺及含量测定方法研究  

Study on preparation process and determination method of Lianfan Zhixie pellets

作　　者：黄德浩 黄丽 何文涛 贺妙兰 叶红斌 刘永 黄源林 胡辉 宋吉明[2] HUANG Dehao;HUANG Li;HE Wentao;HE Miaolan;YE Hongbin;LIU Yong;HUANG Yuanling;HU Hui;SONG Jiming(Huizhou Jiuhui Pharmaceutical Co.,Ltd.,Huizhou 516007,China;Anhui University,Hefei 230039,China)

机构地区：[1]惠州市九惠制药股份有限公司,广东惠州516007 [2]安徽大学,安徽合肥230039

出　　处：《广东药科大学学报》2023年第1期61-65,共5页Journal of Guangdong Pharmaceutical University

基　　金：2020年惠州市科技计划项目(2020SC0109009)。

摘　　要：目的 研究连番止泻微丸制备工艺,建立同时测定微丸中盐酸小檗碱、芍药苷、黄芩苷3种成分含量的方法。方法 以微丸收率和圆整度为指标,确定挤出滚圆法制备微丸的工艺;采用高效液相色谱-双波长法测定含量。结果 当连番止泻干膏粉∶微晶纤维素∶交联羧甲基纤维素钠∶乳糖=2∶4∶1∶3(质量比)、黏合剂为水、挤出转速为40 r/min、滚圆转速200 r/min、滚圆时间为90 min时,制备连番止泻微丸质量较佳;盐酸小檗碱、黄芩苷、芍药苷分别在10.968~109.680μg/mL(r=0.999 9)、4.056~40.560μg/mL(r=0.999 9)和4.128~41.279μg/mL(r=0.999 8)范围内呈良好的线性关系,平均加样回收率分别为98.35%、97.90%、98.01%,RSD分别为1.38%、1.60%、1.18%。结论 该工艺研制的微丸质量指标符合要求,所建立的含量方法专属性强,重复性好,可作为微丸的质量控制方法。Objective To study the preparation process of Lianfan Zhixie pellets and establish a method for simultaneous determination of berberine hydrochloride, paeoniflorin and baicalin in Lianfan Zhixie pellets.Methods The yield and roundness of pellets were taken as indexes to determine the preparation technology of pellets. The content was determined by HPLC-dual wavelength method. Results When Lianpan antidiarrhea dry paste powder∶microcrystalline cellulose∶cross-linked sodium carboxymethyl cellulose∶lactose = 2∶4∶1∶3, the adhesive was water, the extrusion speed was 40 r/min, the rolling speed was 200 r/min, and the rolling time was 90min, the quality of Lianpan Zhixie pellets was better. A good linear relationship of berberine hydrochloride,paeoniflorin and baicalin was observed in the range of 10.968-109.680 μg/mL(r = 0.999 9), 4.056-40.560 μg/mL(r = 0.999 9) and 4.128-41.279 μg/mL(r = 0.999 8). The average recoveries were 98.35%, 97.90% and 98.01%,with RSD of 1.38%, 1.60% and 1.18%, respectively. Conclusion The quality indexes of pellets prepared by this process meet the requirements. The established content method has strong specificity and good repeatability,which can be used as the quality control method of Lianfan Zhixie pellets.

关 键 词：连番止泻微丸 制备工艺 含量测定 HPLC 

分 类 号：R943[医药卫生—药剂学]