复方枫蓼颗粒制备工艺研究
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摘要
优选复方枫蓼颗粒的提取工艺和制备工艺。通过单因素和正交试验,确定最佳提取工艺。并考察浸膏的干燥工艺,采用正交设计法对颗粒剂的辅料配比进行优化,最后按照颗粒剂的质量标准方法进行质量检查。确定复方枫蓼颗粒的最佳醇提取工艺为:10倍量65%的乙醇加热回流提取2次,每次60 min,过滤,合并提取液;减压浓缩至密度为1.15～1.20(60℃)的浸膏,80℃真空干燥成粉。枫蓼颗粒剂的成型工艺为:85%乙醇作润湿剂,药物与辅料比例1∶1.5,糊精与蔗糖比例3∶2制软材,过14目筛,干燥温度60℃,14目筛整粒。本实验确定的提取工艺和制备工艺稳定可行,质量可靠。
To optimize the extracting and processing conditions of Feng Liao Granule. The best extracting and drying process of Feng Liao Granule was optimized by single-factor and orthogonal test. The orthogonal design method was used to optimize the ratio of the excipients of the granules,and finally the quality inspection was carried out according to the quality standard method of the granules. The optimal ethanol process of Feng Liao Granule was 10 times the amount of 65% ethanol was heated and refluxed for 2 times,each time for 60 min,filtered,and the extracts were combined; concentrated under reduced pressure to an extract having a density of1.15 to 1.20( 60 ℃),and vacuum dried at 80 ℃ to form a powder.And the granulation condition was selected.85% ethanol was regarded as wetting agent,the ratio of drug to excipients was 1 ∶ 1.5,and the latter included a ratio of dextrin to sucrose of 3 ∶ 2. then filtered through a 14 mesh screen,dried at 60 ℃. The extracting process and forming process are feasible and stable,and the quality is reliable.
To optimize the extracting and processing conditions of Feng Liao Granule. The best extracting and drying process of Feng Liao Granule was optimized by single-factor and orthogonal test. The orthogonal design method was used to optimize the ratio of the excipients of the granules,and finally the quality inspection was carried out according to the quality standard method of the granules. The optimal ethanol process of Feng Liao Granule was 10 times the amount of 65% ethanol was heated and refluxed for 2 times,each time for 60 min,filtered,and the extracts were combined; concentrated under reduced pressure to an extract having a density of1.15 to 1.20( 60 ℃),and vacuum dried at 80 ℃ to form a powder.And the granulation condition was selected.85% ethanol was regarded as wetting agent,the ratio of drug to excipients was 1 ∶ 1.5,and the latter included a ratio of dextrin to sucrose of 3 ∶ 2. then filtered through a 14 mesh screen,dried at 60 ℃. The extracting process and forming process are feasible and stable,and the quality is reliable.
引文
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[16]乔鹏,袁琦,李佳,等.瓦松颗粒剂制备工艺的研究[J].河南大学学报(医学版),2015,34(03):171-174.Qiao P,Yuan Qi,Li J,et al. Study on granule of orsta.chys fimbriatus[J]. Joural of Henan University(Medical Science)),2015,34(03):171-174.
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[2]郑勉,闵天禄.中国植物志[M].北京:科学出版社,1980,45(1):1-11.Zheng M,Min T L. Flora of China[M] Beijing:Science Press,1980,45(1):1-11.
[3]国家中医药管理局《中华本草》编委会.中华本草[M].上海:科技出版社,1999,4:865-867.Editorial board of state administration of traditional Chinese medicine. The Chinese materia medica[M]. Shanghai Science and Technology Press 1999,4:865-867.
[4]李安仁.中国植物志[M].北京:科学出版社,1998,25(1):3-27.Li A R. Flora of China[M] Beijing:Science Press,1980,25(1):3-27.
[5]中国兽药典委员会.中华人民共和国兽药典[M]. 2010版.北京:中国农业出版社,2011:506-507.Chinese Veterinary Pharmacopoeia Committees. Chinese Veterinary Pharmacopoeia[M]2010. Beijing:China Agriculture Press,2011:249,506-507.
[6]刘明生,刘畅,张小坡,等.中药复方-肠胃康化学成分研究[J].世界科学技术(中医药现代化),2010,12(40):614-616.Liu M S,Liu C,Zhang X P,et al. Chemical Constituents of Compound Changweikang[J]. World Science and Technology/Modernization of Traditional Chinese Medicine and Materia Medica. 2010,12(40):614-616.
[7]刘明生,郭小明,张俊清,等.复方肠胃康中黄酮类成分的研究[J].世界科学技术(中医药现代化),2010,12(5):811-813.Liu M S,Guo X M,Zhang J J,et al. Flavonoids from Prescription changweikang[J]. World Science and Technology/Modernization of Traditional Chinese Medicine and Materia Medica. 2010,12(5):811-813.
[8]王蓓,戎瑞雪,郑聪毅,等.牛耳枫生物碱2-hydroxyyunnandaphnine D体外抗肿瘤活性及作用机制[J].河北大学学报(自然科学版),2013,33(4):401-407.Wang B,Rong R X,Zheng C Y,et al. Anti-tumor activity and the mechanism of 2-hydroxyyunnandaphnine D from Daphniphyllum calycinum in vitro[J]. Journal of Hebei University(Natural Science Edition),2013,33(4):401-407.
[9]杨卫丽,曾祥周,张俊清,等.牛耳枫与辣蓼提取物药效学研究[J].时珍国医国药,2008,19(9):2229-2231.Yang W L,Zeng X Z,Zhang J Q,et al. Pharmacodynamic Study of Extract of Daphniphullum calucinum Benth and Polygonnm Hydropiper Linn[J]. Lishizhen Medicine and Materiamdeica Research 2008,19(9):2229-2231.
[10]刘洪梅,陈玉婷,何立美,等.紫外—可见分光光度法测定枫蓼水煎液中总黄酮含量[J].中国畜牧兽医,2014,4106:140-144.Liu H M,Chen Y T,He L M,et al. Determination of Total Flavonoids in Fengliao Decoction by UV-visible Spectrophotometry[J]. China animal husbandry&Veterinary medicine,2014,4106:140-144.
[11]何立美,陈玉婷,刘洪梅,等.高效液相色谱法同时测定水辣蓼提取物中6种黄酮成分的含量[J].广东农业科学,2014,4113:94-98+118.He L M,Chen Y T,Liu H M,et al. Simultaneous determination of six kinds of flavonoid in extractof Polygonum hydropiper L. by HPLC[J]. Guangdong Agricultural Science,2014,4113:94-98+118.
[12]宋开蓉,刘雄,高建德,等.中药颗粒剂研究现状及展望[J].甘肃中医药大学学报,2017,34(03):79-82.Song K R,Liu X,Gao J D,et al. Research status and prospect of Chinese medicine granules[J]. J. Gansu University of Chinese Medicine,2017,34(03):79-82.
[13]侯小涛,刘鹏,邓家刚,等.均匀设计优选甘蔗叶多糖颗粒制备工艺[J].中成药,2014,36(12):2636-2639.Hou X T,Liu P,Deng J G,et al. The preparation process of sugarcane leaf polysaccharide was optimized by uniform design[J]. Chinese Traditional Patent Medicine,2014,36(12):2636-2639.
[14]赵红,杨家新,汪阳.正交实验在中药中的应用概况[J].新疆中医药,2003(03):64-66.Zhao H,Yang J X,Wang Y. Application of orthogonal experiment in traditional Chinese medicine[J]. Xinjiang traditional Chinese medicine,2003(03):64-66.
[15]苏春梅,杨红,姚金凤.益母草颗粒剂制备工艺研究[J].西部中医药,2015,28(02):27-29.Su C M,Yang H,Yao J H. Xinjiang traditional Chinese medicine[J]. Western Journal of Traditional Chinese Medicine,2015,28(02):27-29.
[16]乔鹏,袁琦,李佳,等.瓦松颗粒剂制备工艺的研究[J].河南大学学报(医学版),2015,34(03):171-174.Qiao P,Yuan Qi,Li J,et al. Study on granule of orsta.chys fimbriatus[J]. Joural of Henan University(Medical Science)),2015,34(03):171-174.
[17]许玲玲,李群力,麻佳蕾,等.杉斛颗粒剂制备工艺研究[J].现代医药卫生,2017,33(22):3389-3391+3395.Xu L L,Li Q L,Ma J L,et al. Study on preparation process of ShanHu granules[J]. J Mod Med Health,2017,33(22):3389-3391+3395.
[18]王秀丽,王晶,王春国,等.慈姑多糖部位颗粒剂制备工艺研究[J].中国现代中药,2017,19(11):1615-1619.Wang X L,Wang J,Wang C G,et al. Study on Preparation Technology of Granules Containing Polysaccharide Parts of Sagittaria sagittifolia[J]. Mod Chin Med,2017,19(11):1615-1619.