中药生产过程质量控制关键技术研究进展

中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。     

针刺京骨穴联合推拿治疗背肌筋膜炎临床研究

目的探讨针刺京骨穴联合推拿治疗背肌筋膜炎的临床疗效。方法将2016年10月—2018年10月收治的背肌筋膜炎患者86例纳入研究,采用随机数字表法分组。对照组43例予以推拿治疗,观察组43例予以针刺京骨穴联合推拿治疗。比较2组患者的治疗总有效率、VAS评分及Oswestry功能障碍指数、痊愈所用时间。结果观察组治疗总有效率为95.3%,而对照组仅为81.4%,差异有统计学意义(P<0.05);2组治疗后VAS评分、Oswestry功能障碍指数均有下降,观察组上述指标低于对照组,差异有统计学意义(P<0.05);观察组痊愈所用时间短于对照组,差异有统计学意义(P<0.05)。结论针刺京骨穴联合推拿治疗背肌筋膜炎的临床疗效突出,可缓解背部疼痛、恢复功能活动,并缩短了愈合时间,提高了生活质量,值得一定的临床推广。     

Sequential Therapy Based on Evolvement of Patterns: A New Model for Treatment of Alzheimer’s Disease

In order to solve the problem of long-term (>9 months) efficacy in the treatment of Alzheimer''s disease (AD) by conventional therapy (CT), a staged and multiply-targeted sequential therapy based on the evolvement of patterns (STEP) was developed. Its main innovations include: (1) the time order of evolution of patterns defined by Chinese medicine (CM) in AD was found, that is, "the orderly pattern evolution starting from Shen (Kidney) deficiency, progressing to phlegm, stasis and fire, and worsening to severe toxin as well as functional collapse"; (2) the cascade hypothesis of Shen deficiency in AD and its sequential therapy based on Shen-reinforcing was proposed, that is, "reinforcing Shen in the early stage and throughout the whole process, resolving phlegm, activating blood and purging fire in the middle stage, detoxifying and replenishing vitality to stop the collapse in the advanced stage", and through meta-analysis, clinical drug use was optimized, thus the leap from "inferential selection" to "evidence-based selection" was realized; (3) the STEP regimen combined with CT maintained cognitive and behavioral stability in AD patients for at least 12 months, with cognitive enhancement and behavioral synergy after 9 months, and cognitive benefit was superior to CT at 9, 12, 15, 18, 21, and 24 months, respectively. The 2-year cognitive improvement rate was increased by 25.64% (P=0.020) and the cognitive deterioration rate was decreased by 48.71% (P=0.000). Among them, the cognitive and functional benefits of Shen-reinforcing therapy for very early AD (350 cases) for 1 year were better than the placebo (P<0.001), and the dementia conversion rate was reduced by 8.85% (P=0.002). The behavioral symptomatic relief of patients with vascular dementia received fire-purging therapy (540 cases) was superior to those received CT (P=0.016). These data suggested that the STEP regimen has synergistic effects on CTs at least in terms of cognitive benefit, and the earlier the use, the greater the benefit will have. Therefore, the STEP regimen should be considered as one of the clinical options, particularly for the dearth of effective pharmaceutical or immunological interventions that are currently available for AD.     

桃红四物汤联合银杏酮酯滴丸治疗老年出血性玻璃体混浊的临床疗效研究

目的:探究桃红四物汤联合银杏酮酯滴丸治疗老年出血性玻璃体混浊的临床疗效。方法:收集2016年12月-2018年12月我院收治的老年出血性玻璃体混浊患者67例,共67眼,根据随机对照表分为对照组和试验组,其中试验组34例,对照组33例,对照组予以银杏酮酯滴丸;试验组在对照组的基础上联用桃红四物汤。两组均服用30 d。治疗结束后对比分析两组患者临床疗效、出血吸收时间、血液流变学及视网膜中央动脉血流动力学。结果:治疗后两组患者高切全血粘度、低切全血粘度、纤维蛋白原、阻力指数(Resistance Index,RI)低于治疗前,收缩期峰值速度(Peak Systolic Velocity,PSV)、舒张末期血流速度(End Diastolic Velocity,EDV)高于治疗前,差异具有统计学意义(P<0.05);治疗后试验组临床总有效率、PSV、EDV高于对照组,出血吸收时间、高切全血粘度、低切全血粘度、纤维蛋白原、RI低于对照组,差异具有统计学意义(P<0.05)。结论:桃红四物汤联合银杏酮酯滴丸治疗老年出血性玻璃体混浊临床疗效显著,适宜临床应用推广。     

Efficacy and safety of herbal medicines for idiopathic Parkinson's disease: a systematic review.

The objective of this study is to assess the efficacy and safety of herbal medicines (HMs), as a monotherapy or adjunct therapy, compared to placebo or conventional approaches in the treatment of idiopathic Parkinson's disease (PD). We conducted a systematic review of randomized controlled trials from both conventional and alternative medicine sources. Outcome measures were overall improvement, quality of life, reduction of levodopa dose, and adverse events. Nine studies were included, each testing a different HM. Six of the trials had limited internal validity due to major flaws in design, including the lack of proper randomization; insufficient blinding; unclear inclusive criteria in terms of diagnostic criteria, baseline staging, and duration of disease; lack of proper sample size calculation; and insufficient data analysis. Imbalances in gender and ethnicity among the patients in the included trials were observed. No major adverse events emerged, and no specific pattern was detected from the trials describing such data. In addition to major methodological defects, heterogeneity in (1) HM tested, (2) control treatment, and (3) outcome measure hindered in-depth data analysis and synthesis. Current evidence is insufficient to evaluate the efficacy and safety of various HMs. Further studies with improved trial design and reporting, with assessment on cost-effectiveness, quality of life, and qualitative data are warranted.     

Traditional Chinese Medicine Compound Mianbu Mixfang Is Effective in Treating Immunological Infertility: a Female Mice

Key words:anTraditional Chinese Medicine has been used to treat various diseases in Chinathousands of years before the introduction of Western Medicine and practices.Inrecent years it has also been used to treat the immunological infertility caused byAs A…     

中国女性的生殖健康权力

<正> 中国的计划生育工作和人口控制的进程取得了举世瞩目的成就,中国妇女在这方面做出了巨大的贡献。在目前的生育调节工作中,妇女承担了几乎全部的生育调节和养育子女的责任及义务。社会、家庭甚至妇女本身都默认和接受了这种程式化的规范。     

善存片联合健脾理气中药预防肿瘤患者化疗所致口腔溃疡的临床观察

目的观察在全身化疗前应用善存片联合健脾理气中药对肿瘤患者口腔溃疡的预防作用。方法将66例肿瘤患者随机分配为治疗组和对照组，每组33例。在全身静脉化疗前3天开始，治疗组每天口服善存片1片及健脾理气中药1剂，对照组服用维生素B：治疗，两组服药化疗后10天为1个疗程。每周期化疗结束后统计口腔溃疡的发生率，共4周期。结果治疗组口腔溃疡的发生率显著降低（P〈0．01）。结论善存片联合健脾理气中药可有效预防及治疗肿瘤患者化疗所致的口腔溃疡。     

对高等教育大众化背景下中医药高等院校专业建设问题的思考

中医药高等院校专业建设应随着社会的进步发展和社会的需求而不断拓宽、延伸其专业领域，本文从中医药高校的专业延伸的必要性、建设原则以及专业延伸的思路等三个方面对中医药高等院校的专业建设工作提出了几点思考。     

预富集-石墨炉原子吸收光谱法测定药食两用中药浸泡液中痕量镉

提供了预富集-石墨炉原子吸收光谱法测定药食两用中药浸泡液中的痕量镉的新方法。采用吡咯烷二硫代氨基甲酸铵(APDC)作配位剂,在pH 5.0-8.0的条件下,用固体硅胶捕集、抽滤分离Cd-APDC配合物,然后用1 moL/L盐酸从膜滤纸上洗下硅胶,得到能够直接用石墨炉原子吸收光谱法测定的镉悬浊液。该法简便快速,富集100倍时的特征质量为2.8×10-14g。用此方法测定4药食两用中药浸泡液中的痕量镉,当n=5时,标准偏差为0.002 5-0.005 8,RSD为:0.012-0.052,样品的加标回收率为91.8%和111.1%,结果较为满意。