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引用本文:何丽君,徐小妹,鄢英慧,陈豪,秦笑笑,程心玲,徐榕青.正交试验优化复方三草滴丸制备工艺[J].中国现代应用药学,2018,35(9):1355-1359.
HE Lijun,XU Xiaomei,YAN Yinghui,CHEN Hao,QIN Xiaoxiao,CHENG Xinling,XU Rongqing.Optimization of Preparation Process of Compound Three Herbs Droplet by Orthogonal Experiment[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(9):1355-1359.
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正交试验优化复方三草滴丸制备工艺
何丽君,徐小妹,鄢英慧,陈豪,秦笑笑,程心玲,徐榕青
福建中医药大学附属人民医院药学部,福建省医学科学研究院福建省医学测试重点实验室,福建中医药大学附属人民医院药学部,福建中医药大学附属人民医院药学部,福建中医药大学附属人民医院药学部,福建中医药大学附属人民医院药学部,福建省医学科学研究院福建省医学测试重点实验室
摘要:
目的 优选复方三草滴丸制备工艺的最佳条件,并测定滴丸中熊果酸的含量。方法 以滴丸的硬度、圆整度、拖尾度、黏连为评价指标,采用正交试验设计方法优选滴丸制备工艺;采用HPLC测定滴丸中熊果酸的含量。结果 滴丸的最佳制备工艺:药物与基质配比为1∶2,PEG 4000与PEG 6000的配比为2∶1,适宜料温为80℃,滴速为每分钟40滴;HPLC测得滴丸中熊果酸的含量为0.992 5 mg·g-1结论 复方三草滴丸制备工艺简便、可行,得到的滴丸圆整度较高、色泽较亮、成形良好、质量可控。熊果酸含量测定方法稳定、可靠,可用于滴丸的质量控制。
关键词:  复方三草滴丸  正交试验  熊果酸  高效液相色谱法
DOI:10.13748/j.cnki.issn1007-7693.2018.09.019
分类号:R284.2
基金项目:福建省科技计划项目(2014Y0060)
Optimization of Preparation Process of Compound Three Herbs Droplet by Orthogonal Experiment
HE Li-jun,XU Xiao-mei,YAN Ying-hui,CHEN Hao,QIN Xiao-xiao,CHENG Xin-ling and XU Rong-qing
Department of Pharmacy,People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine,Fujian Provincial Key laboratory of Medical Measurement,Fujian Academy of Medical Sciences,Department of Pharmacy,People’s Hospital AffiliatedBeginEttoEndETFujian University of Traditional Chinese Medicine,Department of Pharmacy,People’s Hospital AffiliatedBeginEttoEndETFujian University of Traditional Chinese Medicine,Department of Pharmacy,People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine,Department of Pharmacy,People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine,Fujian Provincial Key laboratory of Medical Measurement,Fujian Academy of Medical Sciences
Abstract:
OBJECTIVE To optimize the condition of preparation technique of Compound Three Herbs droplet and determine the content of ursolic acid in the droplet. METHODS Taken the hardness, roundness, trailing degrees and stickiness of the droplets as the index for evaluation, orthogonal experiment was used to optimize preparation technique of the droplet. The content of ursolic acid in the droplet was determined by HPLC. RESULTS The optimal condition of preparation technique was as follows:ratio of drug to matrix was 1:2, ratio of PEG 4000 to PEG 6000 was 2:1, temperature of drug was 80℃, infusion rate was 40 drops per minute. The content of ursolic acid measured by HPLC was 0.992 5 mg·g-1. CONCLUSION The optimal preparation technique in Compound Three Herbs droplet is simple and feasible with good roundness of droplets, bright color, good forming and controllable quality. The method to determine the content of ursolic acid is stable and reliable, which can be used for quality control of droplets.
Key words:  Compound Three Herbs droplet  orthogonal experiment  ursolic acid  HPLC
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