[1] WANG ZhichaoSHI ChangnanSHI YajunLUAN FeiZHANG XiaofeiGUO DongyanZHAI BingtaoLEI GenpingZOU Junbo,.Preparation Process and ThinLayer Chromatography Identification of Xuanfei Zhike Granules [J]. Journal of Shaanxi University of Traditional Chinese Medicine, 2024, (04): 78-86. [doi: 10.13424/j.cnki.jsctcm.2024.04.016]
Preparation Process and ThinLayer Chromatography Identification of Xuanfei Zhike Granules
- Article number:
- 2096-1340(2024)04-0078-09
- Keywords:
- Key words： Xuanfei Zhicough granules; Hesperidin; Orthogonal experiment; HPLC; Thin layer chromatography
- ZTFLH:
- R283.6
- Code:
- A
- 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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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)