乾坤清颗粒制剂工艺、质量标准及芍药苷稳定性的研究

【作者】 闫兴丽；

【导师】 杜守颖；

【作者基本信息】 北京中医药大学 ， 中药制剂学， 2003， 硕士

【摘要】 偏头痛(migrine)是一种常见头痛病，为一种反复发作的血管性头痛，呈一侧或两侧疼痛，常伴恶心、呕吐。目前发病率有逐年增长的趋势。偏头痛给人们带来很大痛苦，临床缺乏有效、毒副作用小的药物，中医药在治疗偏头痛方面以其独到优势受到医药工作者的重视。中医理论认为，偏头痛多因肝气不舒、情志不畅，使脉络瘀阻不通而痛；或是气血亏虚，瘀血阻络而为；或因外感六淫邪气，气滞血瘀所致。根据该病因，采用平肝熄风法、活血化瘀法、健脾化痰法、温阳化浊法。本课题研究的乾坤清颗粒是主要治疗肝郁化火，肝阳上亢所致头晕头痛的中药制剂。该方由白芍、天麻、川芎、延胡索、香附(制)、柴胡、夏天无、黄芩、白芷、半夏10味药组成，是多年来临床总结的有效方剂。本课题在中医药理论的指导下，依照《药品注册管理办法》的要求，对该方进行了制剂工艺、质量标准及稳定性的研究，并对芍药苷的稳定性从温度、湿度和光照等方面进行了深入的研究。在工艺研究中，采用正交试验设计法对本方的十味药材按照含有醇溶性成分、水溶性成分两部分进行工艺路线优选，确定了提取工艺，通过成型工艺研究确定了制法。在质量标准研究中，确定了川芎、延胡索、夏天无、柴胡、天麻、黄芩、白芷的薄层鉴别方法和芍药苷HPLC含量测定方法，规定了原料及制剂中芍药苷的含量限度范围。在乾坤清颗粒稳定性研究中，连续一年留样观察结果表明，稳定性考察所检测的各项指标均符合规定，证明本制剂基本稳定。在芍药苷稳定性试验中，预测了密闭条件下白芍药材、白芍提取物、乾坤清颗粒的有效期；并得出了温度对芍药苷的稳定性的影响与芍药苷存在状态有关，芍药苷在水溶液中不稳定，光照对芍药苷含量无影响的结论。更多还原

【Abstract】 Migrine, which always brings people sufferings, is a sort of common vascular headache, which occurs from time to time with headaches in one side or both sides of the head, and is often accompanied with nausea and vomiting when it comes. At present, since the incidence of migrine is growing, so far there are few modern medications which are effective and with little side-effects are developed and applied in clinic in treating migrine yet, Chinese Medicine accordingly is drawing much attention with its own advantages.From the theory of Chinese Medicine, the supposed causes for the headache of migrine are the obstructed blood in meridians, which might be caused by the disharmony of mood, the stagnation of liver qi,qi and blood deficiency or the six exogenous pathogenic factors. Accordingly the principles should be calming the liver and suppressing wind, promoting blood circulation to reduce the stasis of blood, strengthening the spleen and resolving phlegm, and strengthening yang to evaporate dampness. In this study, a Chinese herbal preparation which is researched pharmaceutically, is an effective prescription in clinical practice, consists of 10 herbs as Radix Paeoniae Alba (Bai Shao),Rhizoma Gastrodiae (Tian Ma),Rhizoma Chuanxiong (Chuan Xiong), Rhizoma Cyperi(prepared Xiang Fu), Radix Bupleuri(Chai Hu), Radix Scutellariae (Huang Qin), Radix Angelicae Dahuricae (Bai Zhi), Rhizoma Pinelliae (Ban Xia), Rhizoma Corydalis yanhusuo (Yan Hu Suo), Rhizoma Corydalis decumbens (Xia Tian Wu).According to the theory of Chinese Medicine, My research has been going on to the requires of "New TCM Medicine Guide", Experiments in process technology, quality standard and stability of "Qiankunqing granule" was tested. And stability of Paeoniaine affected by temperature, humidity and light were deeply studied. Through the study of the preparation process, we selected the preparation process according to the lipophilic parts and hydrophilic parts with the method of orthogonal to certify the extraction process, and studied the shape process to certify the preparation process.By the study of the quality standard, we certified the method of TCM for Rhizpma Chuanxoing, Rhizoma Corydalis, Rhizoma Corydalis Decumbentis, Radix Bupleuri, Rhizoma Gas trodiae and Radix Scutllariae, certified the method of HPLC for paeoniflorin, and determined the limitation of the paeoniflorin in the preparation and the crude drug.According to the results of the stability experiment of the Qiankunqing granule, each determination complied with the requirements. It indicated that the Qiankunqing granule is generally stable.By the stability experiment of paeoniflorin, we determined the term of validity of the<WP=7>paeonia albiflora, the extractor of it and the Qianqingkun granule, concluded that the temperature has different effect on the stability of paeoniflorin in different states. The results indicated that the paeoniflorin is unstable in solution and the illumination has no effect on the stability of paeoniflorin.更多还原