摘要
目的:优选增液承气汤加减直肠栓的制备工艺,并建立栓剂中玄参主要成分哈巴苷和哈巴俄苷的含量测定方法。方法:采用正交试验方法,以提取物得率和哈巴苷、哈巴俄苷的总含量为指标,优选最佳提取工艺;以Suppocire半合成甘油酯为基质,进行药物与基质的配比试验;采用正交试验方法,以外观、重量差异和融变时限为指标,优选最佳制备工艺;HPLC法同时测定栓剂中哈巴苷和哈巴俄苷的含量。结果:最佳提取工艺为加8倍量水,煎煮3次,每次煎煮1 h;最佳制备工艺为基质与药粉比例1∶1,在50℃下熔融,搅拌40 min,在40℃时注模,冷却20 min后脱模;该工艺下制备的3批栓剂中哈巴苷和哈巴俄苷的平均含量分别为1.208 mg/g和0.399 mg/g。结论:制备工艺操作简便、稳定可行,所建含量测定方法精密度、稳定性、重复性好,可作为增液承气汤加减直肠栓的含量测定方法。
Objective:To optimize the preparation process of Zengye Chengqi Decoction Modified Rectal Suppository,and to establish a method for the determination of harpagide and harpagoside in the main components of Xuanshen(Scrophulariae radix)in suppositories.Methods:The orthogonal test method was used to optimize the extraction process with the extraction yield and the total content of harpagide and harpagoside as indexes,the ratio of drug and matrix was tested with supplocire semi synthetic glyceride as matrix,the optimal preparation process was optimized by orthogonal test method with appearance,weight difference and melting time as indexes,and the contents of harpagide and harpagoside in suppository were determined by HPLC.Results:The best extraction process was 8 times of water,decocting for 3 times,each time for 1 h;the best preparation process was that the ratio of matrix to powder was 1∶1,melted at 50℃,stirred for 40 min,injected at 40℃,and demoulded after cooling for 20 min.The average contents of harpagide and harpagoside in the 3 batches of suppositories prepared under this process were 1.208 mg/g and 0.399 mg/g,respectively.Conclusion:The preparation process is simple,stable and feasible.The established content determination method has good precision,stability and repeatability.It can be used as a content determination method for Zengye Chengqi Decoction Modified Rectal Suppository.
作者
邓祥敏
阮仁余
牛敏
DENG Xiang-min;RUAN Ren-yu;NIU Min(Jiangsu College of Nursing,Huai'an Jiangsu 223005,China;Jiangsu Food&Pharmaceutical Science College,Huaiyan Jiangsu 223003,China)
出处
《中医药导报》
2020年第15期66-69,共4页
Guiding Journal of Traditional Chinese Medicine and Pharmacy
基金
淮安市科技计划项目(HABZ201809)。
关键词
增液承气汤加减直肠栓
正交试验
制备工艺
含量测定
哈巴苷
哈巴俄苷
Zengye Chengqi Decoction Modified Rectal Suppository
orthogonal test
preparation process
content determination
harpagide
harpagosid
