紫金化毒栓制备工艺研究  

Optimization on Preparation Technology of Zi-Jin Hua-Du Suppository

作　　者：钱俊[1,2] 刘军 吴云[1,2] 李燕英 吴佳妮 张保献 萧伟[1,2] 

机构地区：[1]江苏康缘药业股份有限公司,连云港222001 [2]中药制药过程新技术国家重点实验室,连云港222001 [3]北京因科瑞斯医药科技有限公司,北京102209

出　　处：《世界科学技术-中医药现代化》2016年第1期88-93,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：科学技术部国家重大新药创制项目(2013ZX09402203):现代中药创新集群与数字制药技术平台;负责人:王振中

摘　　要：目的:优选最佳紫金化毒栓制剂工艺。方法:以外观性状、融变时限、指标成分溶出度为考察指标,优选基质,确定栓剂的载药量、附加剂种类和用量、基质熔融温度、注模及固化温度等工艺条件及参数。结果:栓剂中药物占比37%,辅料为吐温80 1.0%、单硬脂酸甘油酯5.0%、硬脂酸3.0%、半合成脂肪酸甘油酯(36)54.0%。栓剂基质在65℃熔融完全后,加入膏粉,搅拌均匀;待降温至约50℃时,将挥发油用吐温80溶解,加入到药液中,搅拌均匀;待降温至约40℃时,灌注于栓模内,5℃固化10 min,脱模,即得。结论:通过对制剂处方及工艺条件的研究,确定了最佳工艺,并进行了3批中试工艺验证,表明紫金化毒栓制剂工艺合理可行,可用于工业化生产。This study was aimed to optimize the preparation technology of Zi-Jin Hua-Du（ZJHD） suppository.The examining indexes contained appearance,characteristics,melting time,and dissolution of indicators.The matrix was optimized.Technological conditions and indexes,which included the suppository drug-loading rate,the type and amount of additives,matrix melting temperature,temperature of molding and solidification,were identified.The results showed that the best prescription index of ZJHD suppository was drug-Tween 80-glycerin monostearate-stearic acid-adeps solidus（36） at 37%：1.0%：5.0%：3.0%：54.0%.When the suppository matrix was totally melted at the temperature of 65℃,powder was added and mixed evenly.When the temperature was decreased to about 50℃,the essential oil was dissolved with Tween 80,added into the medical liquid,and mixed evenly.When the temperature decreased to about 40℃,the liquid was added into the mold.The solidification was10 min at the temperature of 10℃.The suppository was received after the mold was removed.It was concluded that through the study on the prescription and the technological conditions,the best technology was identified.This technology was verified with three batches of pilot trials.It showed that the ZJHD suppository preparation technology was rational and practicable,which can be used in the industrial manufacture.

关 键 词：紫金化毒栓 绿原酸 制备工艺 高效液相色谱法 

分 类 号：R283[医药卫生—中药学]