银黄解毒胶囊的制备工艺及薄层色谱鉴别研究
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摘要
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.
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.
引文
[1]林慧,梅全喜.中药制剂治疗急性咽炎的研究进展[J].时珍国医国药,2007,18(10):2448-2450.
[2]张霞,谢雁鸣,李光熙,等.中医药治疗急性咽炎的优势与问题探讨[J].中国中药杂志,2017,42(19):3819-3825.
[3]梅娇,袁宏佳,姜展,等.麻苏平喘合剂的制备工艺及薄层色谱鉴别研究[J].中国中医急症,2013,22(8):1319-1320.
[4]郭洪明,袁宏佳,刘兴文.参苓益胃胶囊的制备工艺与薄层色谱鉴别[J].中国药业,2013,22(3):16-17.
[5]赵建平,张玲,张美玲.抗病毒胶囊的制备及薄层鉴别[J].山西中医学院学报,2004,5(3):47-48.
[6]彭红英,江涛,陈雪华,等.追风透骨胶囊提取工艺优选及药效学研究[J].时珍国医国药,2017,28(4):885-887.
[7]富志军,周东新.风湿灵胶囊剂的成型工艺研究[J].中成药,2002,24(1):13-15.
[8]冯宇翔,周静,李敏,等.益气活血胶囊的成型工艺研究[J].中国中医急症,2017,26(9):1517-1518.
[9]何蕾,马慧萍,何晓英,等.雪莲总黄酮胶囊的成型工艺优选[J].中国药房,2015,26(7):967-969.
[10]王化宇,孟美,任钰,等.复方灵丹胶囊成型工艺及质量控制考察[J].中国实验方剂学杂志,2013,19(9):55-59.
[11]国家药典委员会.中华人民共和国药典[M].一部.北京:中国医药科技出版社,2015:158,172,301,303.
[2]张霞,谢雁鸣,李光熙,等.中医药治疗急性咽炎的优势与问题探讨[J].中国中药杂志,2017,42(19):3819-3825.
[3]梅娇,袁宏佳,姜展,等.麻苏平喘合剂的制备工艺及薄层色谱鉴别研究[J].中国中医急症,2013,22(8):1319-1320.
[4]郭洪明,袁宏佳,刘兴文.参苓益胃胶囊的制备工艺与薄层色谱鉴别[J].中国药业,2013,22(3):16-17.
[5]赵建平,张玲,张美玲.抗病毒胶囊的制备及薄层鉴别[J].山西中医学院学报,2004,5(3):47-48.
[6]彭红英,江涛,陈雪华,等.追风透骨胶囊提取工艺优选及药效学研究[J].时珍国医国药,2017,28(4):885-887.
[7]富志军,周东新.风湿灵胶囊剂的成型工艺研究[J].中成药,2002,24(1):13-15.
[8]冯宇翔,周静,李敏,等.益气活血胶囊的成型工艺研究[J].中国中医急症,2017,26(9):1517-1518.
[9]何蕾,马慧萍,何晓英,等.雪莲总黄酮胶囊的成型工艺优选[J].中国药房,2015,26(7):967-969.
[10]王化宇,孟美,任钰,等.复方灵丹胶囊成型工艺及质量控制考察[J].中国实验方剂学杂志,2013,19(9):55-59.
[11]国家药典委员会.中华人民共和国药典[M].一部.北京:中国医药科技出版社,2015:158,172,301,303.