清咽利喉饮制备工艺与质量标准  

Preparation Process and Quality Standard of Qingyanlihou Powder Bag

作　　者：张玉瑛 郑新光 周秋灵 ZHANG Yu-Ying;ZHENG Xin-Guang;ZHOU Qiu-Ling(Department of Pharmacy,Shuangliu District Hospital of Traditional Chinese Medicine,Chengdu 610200,China)

机构地区：[1]成都市双流区中医医院药剂科,成都610200

出　　处：《中国药物经济学》2024年第6期102-107,111,共7页China Journal of Pharmaceutical Economics

基　　金：2020年度成都市医学科研课题(2020017)。

摘　　要：目的对清咽利喉袋泡剂的制备工艺与质量标准进行研究。方法考察清咽利喉袋泡剂制备过程中饮片干燥时间、温度、粉碎粒度、装量等因素对成品质量的影响,综合各因素确定制备工艺。建立浙贝母的鉴别方法,并进行没食子酸含量测定。结果通过正交试验优选出了饮片干燥条件(堆叠厚度3 cm,温度90℃,时间2 h),建立了浙贝母的薄层鉴别方法(乙酸乙酯-甲醇-浓氨试液(17∶2∶1)为展开剂,展开,取出,晾干,喷以稀碘化铋钾试液)与没食子酸的含量测定方法(流动相:甲醇-0.1%磷酸(12∶88);流速:1ml/min;柱温:30℃;检测波长:273nm)。结论该工艺合理、稳定,可作为该制剂的生产工艺;质量检测方法准确、可行,可作为该制剂的内控标准。Objective To study the preparation process and quality standard of Qingyanlihou Powder Bag.Methods The effects of drying time,temperature,particle size and load on the quality of the finished product were investigated,and the preparation technology was determined based on various factors.The identification method of Fritillaria thunbergii was established and the gallic acid content was determined.Results The drying conditions of decoction pieces were optimized by orthogonal test(The stack thickness is 3 cm,the temperature is 90℃,and the time is 2 h),the thin layer chromatography for thunberg fritillary bulb(Ethyl acetate-methanol-concentrated ammonia test solution(17:2:1)was used as the developing agent,unfolded,taken out,dried,and sprayed with dilute bismuth potassium iodide test solution.)and the HPLC method for gallic acid were established(Mobile phase:methanol-0.1% phosphoric acid(12:88);flow rate:1 ml/min;column temperature:30℃;detection wavelength:273 nm).Conclusion The process is reasonable,stable and can be used as the production process of the preparation.The quality detection method is accurate and feasible,and can be used as the internal control standard of the preparation.

关 键 词：清咽利喉袋泡剂 制备工艺 质量标准 

分 类 号：R283.3[医药卫生—中药学] R289.5[医药卫生—中医学]