星点设计-效应面法优化黄芩桑菊抗病毒颗粒的成型工艺
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摘要
目的:优选黄芩桑菊抗病毒颗粒的制粒工艺并考察其加速稳定性。方法:采用星点设计-效应面法,优化筛选颗粒湿法挤压制粒成型工艺中的辅料配比、乙醇浓度及乙醇用量3个主要因素,测定了含量均匀度,并对3批颗粒进行了加速稳定性试验考察。结果:最佳组合是糊精与乳糖之比为2∶1,乙醇浓度为65%,乙醇用量为14%,含量均匀度及加速稳定性均符合要求。结论:本工艺合理可行,所得颗粒质量稳定,可为生产提供参考。
Objective: To prefer molding process of Huangqinsangju Antiviral Granules and to study the accelerated stability of it. Methods: Central composite design-response surface methodology was adopted to optimize materials ratio, ethanol concentration and percentage of ethanol, which were three main factors of wet suppressing formation process of Granules. The content uniformity was determined. The accelerated stability of three batches products was also investigated. Results: The optimal condition for the granulation process was as below.The ratio of dextrin and lactose was 2∶1, 65% ethanol, and the percentage of ethanol was 14%. The accelerated stability and content uniformity was in line with requirements. Conclusion: The forming process is suitable for Granules with good stability, and maybe a useful reference for its production.
Objective: To prefer molding process of Huangqinsangju Antiviral Granules and to study the accelerated stability of it. Methods: Central composite design-response surface methodology was adopted to optimize materials ratio, ethanol concentration and percentage of ethanol, which were three main factors of wet suppressing formation process of Granules. The content uniformity was determined. The accelerated stability of three batches products was also investigated. Results: The optimal condition for the granulation process was as below.The ratio of dextrin and lactose was 2∶1, 65% ethanol, and the percentage of ethanol was 14%. The accelerated stability and content uniformity was in line with requirements. Conclusion: The forming process is suitable for Granules with good stability, and maybe a useful reference for its production.
引文
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[2]王本祥.现代中药药理学[M].天津:天津科学技术出版社,1997:299.
[3]国大亮,何新,刘玉璇,等.黄芩苷鼻用凝胶的制备及其经鼻扩散研究[J].中草药,2013,44(10):1253.
[4]吴伟,崔光华.星点设计-效应面优化法及其在药学中的应用[J].国外医学:药学分册,2000,27(5):292-298.
[5]尚雅文,龚慕辛,翟永松,等.星点设计-效应面法优选糖肾宁颗粒的成型工艺[J].中国实验方剂学杂志,2015,21(16):15.
[6]史亚军,王昌利,赵海峰,等.星点设计-效应面法优选止鼾颗粒成型工艺[J].中成药,2014,36(9):1864.
[7]罗超,罗越,陈麒同,等.颗粒剂制备方法的研究进展[J].甘肃科技,2014,30(21):140-141.
[8]付建武,涂瑶生,孙冬梅,等.抗感冒颗粒的处方筛选[J].中国药房,2013,24(15):1371-1373.
[9]罗友华,黄亦琦.中药颗粒剂辅料的研究进展[J].海峡药学,2002,14(1):1-3.
[10]陈卫卫,何炜玲,冯看,等.星点设计-效应面法优选抗炎退热颗粒剂的成型工艺[J].中成药,2011,33(9):1610-1612.
[11]Hassan EE,Parish RC,Gallo JM.Optimized formulation of magnetic chitosan microspheres containing the anticancer agent,oxantrazole[J].Pharm Res,1992,9(3):390-397.
[12]陈卫卫,农玉梅,梁丹,等.星点设计-效应面法优选消疮颗粒剂的成型工艺[J].中药材,2010,33(5):801-803.
[13]刘峰.HPLC法测定七制香附丸中芍药苷和黄芩苷的含量[J].药学研究,2013,32(8):449-451.
[14]李耀华,蔡乐,钟鸣,等.解毒抗白颗粒剂的含量测定及初步稳定性研究[J].中国实验方剂学杂志,2013,19(3):97-99.
[15]邱颖,朱玲,孙晓英.星点设计-效应面优化法与正交设计和均匀设计的比较及其在药剂研究[J].海峡药学,2011,23(2):18-20.
[16]史亚军,王昌利,赵海峰,等.星点设计-效应面法优选止鼾颗粒成型工艺[J].中成药,2014,36(9):1863-1865.
[17]国家药典委员会.中国药典:四部[S].北京:中国医药科技出版社,2015:7,124.
[18]郑育平.儿科用药特点与儿科合理用药[J].中医药临床杂志,2004,16(1):13-14.
[19]刘健惠.关爱儿童,关注儿童用药[J].上海医药,2013,34(1):41-42.
[20]韩丽,张芳,张定堃,等.中药制剂含量均匀度的测定方法初探[J].中草药,2014,45(15):2125-2126.