作者机构：
[朱香梅; 石雨荷; 谭洋; 陈聪; 裴刚] College of Pharmacy, Hunan University of Chinese Medicine, Changsha, 410208, China;Yueyang Traditional Chinese Medicine Hospital, Yueyang, 414000, China;[童巧珍] College of Pharmacy, Hunan University of Chinese Medicine, Changsha, 410208, China, Yueyang Traditional Chinese Medicine Hospital, Yueyang, 414000, China
通讯机构：
[Tong, Q.; Pei, G.] C;College of Pharmacy, China
摘要：
Objective:To observe the clinical effect of the Liuwei Wenxin granule(六味温心颗粒)on cardiac function,plasma BNP and MMP-3 in patients with chronic heart failure.Methods:124 patients were randomly divided into the control group and the treatment group,62 cases in each group.The control group was given CHF routine treatment.The treatment group was given the Liuwei Wenxin granule more.Results:The total efficiency,marked rate and cardiac function in the treatment group were significantly better than the control group(P<0.05).Plasma BNP and MMP-3 level in the treatment group were significantly decrease(P<0.05).Conclusion:The Liuwei Wenxin granule can reduce plasma BNP and MMP-3 levels,obviously improve the clinical symptoms from CHF and has guiding significance for clinical practice and is worthy of clinical promotion.
作者机构：
[蔡雄] Institute of Innovation and Applied Research in Chinese Medicine, Hunan University of Chinese Medicine, Hunan, Changsha, 410208, China;[陈聪; 李鑫; 彭清华; 宋厚盼] School of Basic Chinese Medical Sciences, Hunan University of Chinese Medicine, Hunan, Changsha, 410208, China;[王炜] School of Pharmaceutical Sciences, Hunan University of Chinese Medicine, Hunan, Changsha, 410208, China;[唐琳] School of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangdong, Guangzhou, 510224, China;[刘良] State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Macau, 999078, Macau
通讯机构：
[CAI, X.] I;Institute of Innovation and Applied Research in Chinese Medicine, Hunan, China
关键词：
青附蠲痹汤;类风湿关节炎;制备工艺;质量控制;安全性;抗炎镇痛
摘要：
Objective Qing Fu Juan Bi Tang (QFJBT) is an anti-arthritic Chinese medicine formula consisting of five herbs: Aconiti Lateralis Radix Praeparata (Fu Zi, 附子), Sinomenii Caulis (Qing Feng Teng, 青风藤), Astragali Radix (Huang Qi, 黄芪), Paeoniae Radix Alba (Bai Shao, 白芍) and Moutan Cortex (Mu Dan Pi, 牡丹皮), which have well-established histories of use for treatment of rheumatic and arthritic diseases. We intended to establish the optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT to develop it as a novel botanical drug product for treatment of rheumatoid arthritis (RA). Methods The combinative approaches of chemical assessment, toxicological and pharmacological evaluation were explored to define the pharmaceutical preparation of QFJBT. Results The optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT were established in terms of greatest chemical contents of bioactive constituents, potent anti-inflammatory and antinociceptive activities, and favorable safety profile. Quality analysis of the pilot product of QFJBT by high-performance liquid chromatography (HPLC) demonstrated that the chromatographic fingerprint profiles of three batches of QFJBT were basically identical and the contents of four characteristic and bioactive markers were relatively consistent. General toxicological studies showed a favorable safety profile of QFJBT. The maximum tolerated single dose of QFJBT was determined in both sexes of rats to be 33.63 g/kg body weight which is equivalent to 346 times of clinical dose. In the chronic oral toxicity study, the results of laboratory investigation showed that QFJBT at doses of 3.89, 6.80 and 9.72 g/kg body weight (equivalent to 40, 70 and 100-fold clinical doses, respectively) caused no changes in all hematological parameters and blood biochemical parameters of rats. No mortality or specific toxic responses were observed in animals after three months of repeated dosing with QFJBT. Conclusion The optimized and standardized pharmaceutical and manufacturing processes for the production of QFJBT have been successfully screened and identified through established rigorous in-process controls.
摘要：
目的探讨加味丹参饮通过调节鸟氨酸脱羧酶（ODC）活性在抗SD大鼠心肌缺血再灌注损伤（IRI）中的保护机制。方法建立SD大鼠心肌IRI模型,设对照组、假手术组、缺血再灌注损伤（IRI）组、加味丹参饮（JWDSY）+IRI组共4组。酶联免疫（ELISA）法测定ODC含量,实时荧光定量PCR（RT-PCR）方法检测ODC m RNA表达水平,免疫印迹（Western blot）法检测ODC蛋白表达水平,高效液相色谱检测心肌组织中多胺的含量。结果与对照组比较,假手术组的ODC含量、ODC m RNA及蛋白表达水平均无统计学意义（P>0.05）;与假手术组比较,IRI组的ODC含量显著增加、ODC m RNA及蛋白表达水平显著升高,差异有统计学意义（P<0.01）;与IRI组比较,JWDSY+IRI组ODC含量显著减少,ODC m RNA和蛋白表达水平显著降低,差异有统计学意义（P<0.01）。结论加味丹参饮可能通过调节ODC活性,从而发挥对IRI后心肌的保护作用。
