银黄解毒胶囊的制备工艺及薄层色谱鉴别研究

Study on Preparation Process and TLC Identification of Yinhuang Jiedu Capsules

目的:研究银黄解毒胶囊的制备工艺并初步建立其内控质量标准。方法:以浸泡时间、加水量、煎煮时间为影响因素,以浸膏得率为评价指标,采用正交试验法进行提取工艺研究,并以润湿剂选择、辅料种类的筛选、堆密度的测定、胶囊型号及颗粒的CRH为考查因素,进行成型工艺研究;采用TLC法对黄连、黄芩、赤芍、牡丹皮进行定性鉴别。结果:优选的提取工艺为提取2次,分别加8倍和6倍量水,浸泡0.5 h,煎煮2 h和1.5 h。成型工艺:95%乙醇作为润湿剂,淀粉为辅料,控制CRH为67%以下进行胶囊灌装。TLC法简便可靠,专属性强,阴性对照溶液无干扰。结论:优选的工艺条件稳定、合理,为银黄解毒胶囊下一步临床试验研究和临床合理用药提供了科学依据,为其质控分析建立了可行性鉴别方法。

Objective: To study the preparation process and establish its internal control standard of Yinhuang Jiedu Capsules. Methods: Orthogonal test studied the extraction process by taking the soaking time, water addition and decoction time as the influence factors, using the extractive yield as evaluation index, and through the selection of wetting agent, the selection of auxiliary materials, the determination of heap density and the hygroscopic curve and CRH of capsule type and granule, to study the molding process, using TLC to identify Coptis chinensis Franch, Scutellaria baicalensis Georgi, Paeonia lactiflora Pall, Paeonia suffruticosa Andr. Results: extraction process:the water soaking time is 0. 5 h and the water has been extracted twice with the amount of water addition is 8 times and 6 times( and the decoction time is 2 h and 1. 5 h, respectively;preparation process: 95% ethanol as wetting agent,starch as an auxiliary, and CRH under 67% are suitable for capsule filling, the method is simple, reliable, exclusive, and the negative control has no interference. Conclusion : It may lay a foundation for the further clinical trial research, and provide scientific basis for clinical rational drug use. The quality control method is specific and sensitive.