院内制剂参芪归芍颗粒的制备工艺优化及质量标准的建立
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摘要
目的优化参芪归芍颗粒的提取工艺及建立稳定可靠的质控标准。方法水煎煮工艺采用正交试验法进行优化。黄芪、川芎、当归、茯苓的定性鉴别方法为薄层色谱法。结果提取工艺确定为煎煮提取3次,每次2 h,加水量为8倍;制粒辅料为乳糖,乳糖和稠膏的质量比为2:1;颗粒溶化性、成型性好;鉴别方法稳定可靠。结论参芪归芍颗粒生产工艺简便易行,适合工业化生产。黄芪、川芎、当归、茯苓定性鉴别的斑点清晰,重现性好,方法专属性强。
Objective To optimize the preparation technology and set up the quality standards of Shenqi Guishao granulas. Methods The orthogonal test was adopt to check the decoction technology. The thin layer chromatography(TLC) was performed to identify Astragall Radix, Chuanxiong Rhizoma, Angelicae Sinensis Radix, Poria of the Shenqi guishao Granulas. Results The extraction process was determined as three times of decoction for 2 hours each time, the amount of water added was 8 times; the granulation excipient was lactose, the mass ratio of lactose to thick paste was 2:1; the granulation dissolution was good,the formability was good; the identification method was stable and reliable. Conclusion The preparation process of Shenqi Guishao granulas was simple and convenient that can be used for industrial production. The results of the thin-layer chromatography show that the qualitative identification of the Astragall Radix,Chuanxiong Rhizoma, Angelicae Sinensis Radix,Poria is clear,the reproducibility is good,and the method is highly specific.
Objective To optimize the preparation technology and set up the quality standards of Shenqi Guishao granulas. Methods The orthogonal test was adopt to check the decoction technology. The thin layer chromatography(TLC) was performed to identify Astragall Radix, Chuanxiong Rhizoma, Angelicae Sinensis Radix, Poria of the Shenqi guishao Granulas. Results The extraction process was determined as three times of decoction for 2 hours each time, the amount of water added was 8 times; the granulation excipient was lactose, the mass ratio of lactose to thick paste was 2:1; the granulation dissolution was good,the formability was good; the identification method was stable and reliable. Conclusion The preparation process of Shenqi Guishao granulas was simple and convenient that can be used for industrial production. The results of the thin-layer chromatography show that the qualitative identification of the Astragall Radix,Chuanxiong Rhizoma, Angelicae Sinensis Radix,Poria is clear,the reproducibility is good,and the method is highly specific.
引文
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[2]刘会芳,金喆,冯青根,等.后循环缺血性眩晕中医辨证治疗进展[J].中医药临床杂志, 2017, 29(11):1959-1961.
[3]曹华伟.补阳还五汤联合西比灵治疗后循环缺血性眩晕的疗效分析[J].当代医药论丛, 2017, 15(20):196-197.
[4]许程燕,吕江华,蒙燕颖.小续命汤加减治疗后循环缺血性眩晕36例临床观察[J].深圳中西医结合杂志, 2017,27(18):50-51.
[5]严容,丁煜,徐佳杨.从痰瘀论治后循环缺血性眩晕40例[J].江西中医药, 2017, 48(9):50-51.
[6]魏中原.后循环缺血性眩晕急性发作期证候相关危险因素分析[J].深圳中西医结合杂志, 2017, 27(16):118-120.
[7]张晓琴.清眩化痰汤治疗后循环缺血性眩晕的临床观察[J].中国民间疗法, 2017, 25(8):55-56.
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[9]邓华,张选国.后循环缺血性眩晕患者中医体质分析[J].陕西中医, 2017, 33(8):1008-1009.
[10]刘宇珍,庞谢辉.正交设计优化鸡骨草颗粒剂制备工艺[J].卫生职业教育, 2017, 35(19):104-105.
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[13]冯宇翔,周静,李敏,等.益气活血胶囊的成型工艺研究[J].中国中医急症, 2017, 26(9):1517-1518.
[14]王飞,李金景,张明月.葛根-山楂祛脂颗粒的制备及处方优化[J].枣庄学院学报, 2017, 34(5):99-104.
[15]崔霞,毕建云,张震宇,等.血府逐瘀颗粒的制备工艺研究[J].山东化工, 2017, 46(16):24-27.
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[18]曾棋平,杨丽娜,王艺红,等.气血双补口服液的稳定性研究[J].药学服务与研究, 2017, 17(5):384-387.
[19]马静,宋毅,费小凡.鼻窍通颗粒中黄芪、黄芩的薄层鉴别研究[J].华西医学, 2017, 32(9):1409-1413.
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[25]李亚萍,王兆华,张大军.明目疏脉片质量标准研究[J].山东化工, 2017, 46(17):94-96.
[26]李劲松.健脑灵片质量标准中的成分鉴别和芍药苷含量测定研究[D].武汉:湖北工业大学, 2017.
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[29]曹瑞,曹林林,郭东艳,等.天麻眩晕宁片的薄层色谱鉴别研究[J].云南中医学院学报, 2016, 39(4):26-29.
[30]刘金坤,王琴,白殊同,等.六味地黄口服液薄层色谱鉴别研究[J].中国药业, 2016, 25(13):68-70.
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