【作者】 李少华；

【导师】 赵学军；

【作者基本信息】 广州中医药大学 ， 中药学， 2010， 硕士

【摘要】 温中清肠胶囊由干姜、黄连、陈皮、柴胡、法半夏、五味子、香附、甘草等八味药组成,具有温脾健胃、疏肝清肠之功。临床上用于治疗脘腹疼痛、腹胀、腹泻,大便异常等寒热错杂型肠易激综合症。本项目针对目前市面上尚未有专门治疗寒热错杂型肠易激综合症药物,对温中清肠汤进行开发。在中医药理论指导下,结合现代制药工艺技术,对温中清肠胶囊的制备及质量标准进行研究。本论文主要包括温中清肠胶囊制备工艺和质量标准研究方面的内容。研究内容与结果如下：干姜、黄连、五味子、香附用乙醇提取,以黄连药材中盐酸小檗碱提取率及醇提得膏率为指标,采用正交试验考察乙醇浓度、乙醇用量、提取时间、提取次数等因素对黄连中盐酸小檗碱提取率的影响。通过正交试验确定最佳工艺参数为加10倍量70%乙醇,回流提取2次,每次1小时。在此工艺条件下,盐酸小檗碱提取率在65%左右,得膏率在23.34%。结合文献资料,醇提药味中干姜、黄连、五味子等水提物均含与本制剂有关的药理学结果,故醇提物药渣与陈皮、柴胡、法半夏、甘草一起水提,以陈皮中的橙皮苷提取率及水提得膏率为指标,采用正交试验考察加水量、提取时间、提取次数等因素对提取率的影响。通过正交试验确定最佳工艺参数为：用10倍量水提取2次,每次2小时。在此工艺条件下,橙皮苷的提取率均在57%左右,得膏率在29%左右。将上述提取液真空浓缩(真空度：-0.06--0.08Mpa,温度<70℃,浓缩至相对密度1.30(50℃),真空干燥成浸膏,加入适量预胶化淀粉,微晶纤维素,羧甲基淀粉钠(CMS-Na),硬脂酸镁,干法制粒,填充成0.5g胶囊。在质量标准研究中,我们初步制定了温中清肠胶囊的质量标准。采用薄层色谱法对方中黄连、五味子、香附、陈皮、甘草等药味进行了定性鉴别,结果表明选择特异性强,斑点清晰,重现性良好；建立了盐酸小檗碱的HPLC含量测定方法,暂定本品中盐酸小檗碱的含量不得低于1.56mg/粒,色谱条件为：色谱柱：Phenomenex Luna C18 (2)(4.6mm×250mm,5μm)；流动相：乙腈-0.1%KH2P04(50:50);检测波长：345nm；流速：1.0mL·min-1;理论塔板数按盐酸小檗碱峰计算不应低于3000。在该色谱条件下,盐酸小檗碱与其它成分可达基线分离,方中其它成分对测定无干扰,平均回收率达到100.50%(RSD=1.77%),同时,我们按照中国药典2005版一部附录I J胶囊剂下各项规定对制剂进行检查,均符合要求。通过对温中清肠胶囊制备工艺和质量标准的系统研究,为本品种工业化大生产和质量控制提供了科学依据,保证了制剂质量。更多还原

【Abstract】 Wenzhongqingchang Capsule is made of Rhizoma Gingiberis, Rhizoma Coptidis, Pericarpium Citri reticulatae, Radix Bupleuri, Rhizoma Pinelliae Praeparatum, Fructus Schisandrae chinensis, Rhizoma Cyperi, Radix Glycyrrhizae with the curative effects of Enhanced digestion and antidiarrheal.It is mainly used to treat Irritable Bowel Syndrome, Under the guidance of Traditional Chinese Medicine Theory, this project studied on the preparation and quality control of Wenzhongqingchang Capsule combining the modern pharmacy technology. The results were as follows:Choosing berberine hydrochloride, the main component in Rhizoma Coptidis and drugs have anointed rate as index, With this index we investigated the influence of the four factors (concentration of alcohol, amount of alcohol, extraction time and extraction frequency) on the extraction of Rhizoma coptidis. By orthogonal test we determined the process parameter:extract the herbs 2 times with 10 times amount of 70% alcohol for 1 hours, and then put the filtrate together. In this way, the extraction rates of berberine hydrochlorid is around 65%, drugs have anointed rate is 23.34%.Combination of literature, Rhizoma Gingiberis, Rhizoma Coptidis, Fructus Schisandrae chinensis, extract inclusive of water is related with the pharmacology of this agent results. so water extract the alcohol extract residue with Pericarpium Citri reticulatae, Radix Bupleuri, Radix Glycyrrhizae, Rhizoma Pinelliae. Choosing Hesperidin, the main component in Pericarpium Citri Reticulatae and drugs have anointed rate as index, with the extract 2 times, used tenfold water extracting 2.0 hours, In this way, the extraction rates of berberine hydrochlorid is around 57%, drugs have anointed rate is around 29%.Merging the extraction, Vacuum concentration (vacuum:-0.06--0.08Mpa, Temperature<70℃, To concentrate the relative densityl.30 (50℃)), Vacuum drying, crushing into fine powder, standby. Adding some Pre-gel starch, microcrystalline cellulose, carboxymethyl starch sodium to the two mixtures above, dry pressing and granulating, adding some magnesium stearate, split charging. Loaded capsules weight 0.5g.Study the quality standard, we explored the TLC identification of Rhizoma Coptidis, Pericarpium Citri Reticulatae, Fructus Schisandrae Chinensis, Rhizoma Cyperi, Radix Glycyrrhizae in the Wenzhongqingchang Capsule, choosing a clear-spotting, well-reproducing and specific TLC identification for the quality standard. We established a HPLC method to determine the contents of berberine hydrochloride simultaneously, and made a methodological study. The results showed that the method was convenient, stable and well-reproducing and without interference from the negative control, which can be a control standard for the Wenzhongqingchang Capsule. We According to China pharmacopoeia 2005 version of an appendix I J capsule under the provisions of preparations for inspection, meets the requirement.Systematic studying on the preparation technology and quality standard of Wenzhongqingchang Capsule, it could afford scientific basis for industrialization and quality control and its quality and clinical effect can be guaranteed.更多还原