秦艽喷膜剂的制备工艺研究及其质量标准建立  

Preparation and quality standard of film spraying agent of Gentiana macrophylla

作　　者：李松洋 邓妍 杨放 雷诗懿 高天赐 杨敏[2] 徐玉玲[2,4] LI Song-yang;DENG Yan;YANG Fang;LEI Shi-yi;GAO Tian-ci;YANG Min;XU Yu-ling(School of Food and Bioengineering,Chengdu University,Chengdu 610106,China;School of Pharmacy,Chengdu University,Chengdu 610106,China;Sichuan Key Laboratory of New Drug Pilot Test,Chengdu Tianhe Traditional Chinese and Western Medicine Technology Conservation Co.,Ltd.,Chengdu 610106,China;Sichuan Antiviral Chinese Medicine Industrialization Engineering Technology Research Center,Chengdu 610106,China)

机构地区：[1]成都大学食品与生物工程学院,四川成都610106 [2]成都大学药学院,四川成都610106 [3]成都天河中西医科技保育有限公司新药中试四川省重点实验室,四川成都610106 [4]四川省抗病毒中药产业化工程技术研究中心,四川成都610106

出　　处：《中草药》2022年第20期6462-6471,共10页Chinese Traditional and Herbal Drugs

基　　金：四川省2021—2023年高等教育人才培养质量和教学改革项目(JG2021-1106);新药中试四川省重点实验室开放课题资助项目(XYZS2022-01);成都大学2021—2023年研究生人才培养质量和教学改革立项项目(cdjgy2022004)。

摘　　要：目的 制备秦艽Gentiana macrophylla喷膜剂,并建立其质量标准。方法 结合层次分析法(analytic hierarchy process,AHP),以成膜时间、挥发量、含量均匀度、膜的显微性状、黏性为指标对成膜辅料的种类及用量进行筛选;以保湿性为指标,对甘油的比例进行考察;以有效成分龙胆苦苷的累积释放量为指标,筛选出合适的促渗剂及其用量;采用HPLC对秦艽喷膜剂中有效成分龙胆苦苷进行含量测定,并建立包括保湿性等多个检查项在内的秦艽喷膜剂质量标准。结果 确定成膜处方为6%聚乙烯吡咯烷酮K30(polyvinyl pyrrolidone K30,PVP)和0.2%甲基纤维素MC-400(methyl cellulose-400,MC),促渗剂处方为2.5%丙二醇和2.5%氮酮;建立秦艽喷膜剂质量标准为秦艽喷膜剂含龙胆苦苷不得少于0.76 mg/mL;保湿性不得低于30.25%;成膜时间不得高于240 s;挥发量不得低于62.70%;成膜后433 nm处吸光度(A)值不得大于0.142,成膜中A值不得小于0.259;运动黏度不得低于6.91 mm^(2)/s;样品p H值为3.67~5.50。结论 筛选所得秦艽喷膜剂的制备工艺稳定,建立的质量标准为秦艽喷膜剂质量评价提供依据。Objective To prepare film spraying agent of Gentiana macrophylla and eatablish the quality control method. Methods Combined with the analytic hierarchy process(AHP),the film forming time,volatilization,content uniformity,film property and viscosity were used to screen the type and dosage of film forming excipients. The proportion of glycerin was investigated by using moisture retention as an index. The cumulative release amount of gentiopicroside,an effective component,was used as an indicator to screen out the appropriate type and dosage of penetration enhancers. HPLC was used to determine the content of gentiopicrin,the active ingredient in G. macrophylla film spray. The moisture retention,film forming time,volatilization,viscosity,fluidity and pH value were studied to establish the quality standard of G. macrophylla film spray. Results The membrane forming prescription is 6% polyvinyl pyrrolidone K30 and 0.2% methyl cellulose-400,and the osmotic enhancer prescription is 2.5% propylene glycol and 2.5% azone. The quality standard of G. macrophylla film spray was established as follows: gentiopicrin in 1 mL was determined to be no less than 0.76 mg;temporary moisture retention shall not be less than 30.25%;film forming time should not be higher than 240s;volatilization should not be less than 62.70%;after film forming,the absorbance at 433 nm shall not be greater than 0.142,and the absorbance in film forming shall not be less than 0.259;kinematic viscosity shall not be less than 6.91 mm^(2)/s;the pH of the samples was 3.67 to 5.50. Conclusion The optimized preparation process of G. macrophylla film spray is stable,and the established quality standard provides a certain basis for the quality evaluation of G. macrophylla film spray.

关 键 词：秦艽 喷膜剂 龙胆苦苷 质量标准 层次分析法 保湿性 

分 类 号：R283.6[医药卫生—中药学]