[1]王智超石长楠史亚军栾飞 张小飞郭东艳 翟秉涛雷根平邹俊波.宣肺止咳颗粒的制备工艺及薄层色谱鉴别[J].陕西中医药大学学报,2024,(04):078-86.[doi:10.13424/j.cnki.jsctcm.2024.04.016]
　WANG ZhichaoSHI ChangnanSHI YajunLUAN FeiZHANG XiaofeiGUO DongyanZHAI BingtaoLEI GenpingZOU Junbo.Preparation Process and ThinLayer Chromatography Identification of Xuanfei Zhike Granules[J].Journal of Shaanxi University of Traditional Chinese Medicine,2024,(04):078-86.[doi:10.13424/j.cnki.jsctcm.2024.04.016]
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宣肺止咳颗粒的制备工艺及薄层色谱鉴别()
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《陕西中医药大学学报》[ISSN:2096-1340/CN:61-1501/R]

卷:
期数:
2024年04期
页码:
078-86
栏目:
出版日期:
2024-07-17

文章信息/Info

Title:
Preparation Process and ThinLayer Chromatography Identification of Xuanfei Zhike Granules
文章编号:
2096-1340(2024)04-0078-09
作者:
王智超1石长楠2史亚军1栾飞1 张小飞1郭东艳1 翟秉涛11雷根平3邹俊波1
1.陕西省中药基础与新药研究重点实验室/陕西中医药大学药学院，陕西 咸阳 712046;
2.西安恒生堂制药有限公司，陕西 西安 710000；
3.陕西中医药大学附属医院，陕西 咸阳 712046
Author(s):
WANG Zhichao1SHI Changnan2SHI Yajun1LUAN Fei1ZHANG Xiaofei1GUO Dongyan1ZHAI Bingtao1LEI Genping3ZOU Junbo1
1.Key Laboratory of Traditional Chinese Medicine and New Drug Research in Shaanxi Province/School of Pharmacy，Shaanxi University of Traditional Chinese Medicine，Xianyang，Shaanxi 712046;
2.Xi’an Hengshengtang Pharmaceutical Co.，Ltd.，Xi’an，Shaanxi 710000;
3.Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine，Xianyang，Shaanxi 712046
关键词:
关键词：宣肺止咳颗粒; 橙皮苷; 正交实验; HPLC; 薄层色谱
Keywords:
Key words： Xuanfei Zhicough granules; Hesperidin; Orthogonal experiment; HPLC; Thin layer chromatography
分类号:
R283.6
DOI:
10.13424/j.cnki.jsctcm.2024.04.016
文献标志码:
A
摘要:
摘 要：目的 筛选宣肺止咳颗粒剂制备成型稳定可行的最优工艺，为其质量研究奠定基础。方法 选用橙皮苷含量和干膏率的不同权重比为综合评价指标，进行单因素实验，发现提取次数、时间及处方加水倍数对实验结果影响显著，故对饮片粉碎粒度、浸泡时间不予考虑，以此为基础进行正交实验，最终优选出宣肺止咳颗粒的水提工艺。考察药液比、高速离心的转速和时间，筛选出较优的药液除杂工艺；将常压浓缩与减压浓缩药液的橙皮苷峰面积、干膏率进行比较，确定浓缩工艺；选用减压干燥方法进行干燥，并确定该方法的可行性；选用不同浓度乙醇，将玉米淀粉和糊精（1∶1）、蔗糖和糊精（1∶1）与干膏粉分别混合进行制粒，对比制得颗粒的性状，筛选出成型工艺。根据2020版《中国药典》一部，对宣肺止咳方中的瓜蒌皮、清半夏两味药材进行定性鉴别，并对宣肺止咳颗粒橙皮苷含量测定的方法建立质量标准。结果 全方加10倍量水，提取2次，每次60 min；浓缩至药液比为1∶3，选用高速离心法分离纯化，固定转速4000 r·min-1，时间10 min；在80 ℃下进行减压浓缩，结果最优；减压干燥方法稳定可靠，适用于本方；优选出糊精和玉米淀粉（1∶1）与药膏干粉1∶1混合，喷洒90%乙醇，制得的颗粒性质最好；宣肺止咳颗粒橙皮苷含量测定方法稳定可行；薄层鉴别方法简便可靠。结论 筛选出的宣肺止咳颗粒的制备工艺稳定可靠、科学合理，可应用于企业化大生产。
Abstract:
Abstract： Objective To screen the optimal process for the stable and feasible preparation of Xuanfei Zhike granules，and lay the foundation for its quality research.Methods The method selected the different weight ratios of hesperidin content and dry ointment rate as the comprehensive evaluation indicators，and conducted a single factor experiment.It was found that the extraction frequency，time，and prescription water addition ratio had a significant impact on the experimental results.Therefore，the crushing particle size and soaking time of the decoction pieces were not considered.Based on this，an orthogonal experiment was conducted to ultimately optimize the water extraction process of Xuanfei Zhike granules.Examine the drug liquid ratio，high-speed centrifugation speed and time，and select the optimal drug liquid impurity removal process;Compare the peak area and dry paste rate of hesperidin in normal pressure concentration and vacuum concentration solutions to determine the concentration process;Select the vacuum drying method for drying and determine the feasibility of this method;Using different concentrations of ethanol，corn starch and dextrin (1∶1)，sucrose and dextrin (1∶1) were mixed with dry paste powder for granulation，and the characteristics of the particles were compared to select the molding process.According to the 2020 edition of the Chinese Pharmacopoeia，qualitative identification of Gualou Pi and Qingbanxia in Xuanfei Zhike formula was conducted，and a quality standard was established for the determination of hesperidin content in Xuanfei Zhike granules.Results Add 10 times the amount of water to the entire formula，extract twice for 60 minutes each time;Concentrate until the drug liquid ratio is 1∶3，use high-speed centrifugation for separation and purification，fix the speed at 4000 r·min-1，and time for 10 minutes;The best result was obtained by vacuum concentration at 80 ℃;The vacuum drying method is stable and reliable，suitable for our own formula;Mix dextrin and corn starch (1∶1) with ointment dry powder in a 1∶1 ratio and spray 90% ethanol to obtain the best particle properties;The method for determining the content of hesperidin in Xuanfei Zhike granules is stable and feasible;The thin layer identification method is simple and reliable.Conclusion The preparation process of Xuanfei Zhicough granules selected is stable，reliable，scientifically reasonable，and can be applied to large-scale enterprise production.

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备注/Memo

备注/Memo:
基金项目：陕西省中药制药重点学科资助项目（303061107）;陕西省中医药管理局中药制药工程重点学科（2017001）；陕西省中医药管理局中医药防治新冠病毒感染科研攻关项目（ZYJXG-Y23002，ZYJXG-Y23004）;陕西中医药大学学科创新团队项目(2019-YL11)
更新日期/Last Update: 2024-07-11