目的 研究无硫党参饮片的安全性、有效性质量标准,为其质量监控和临床应用提供参考.方法 分别采用薄层色谱法、气相色谱法测定来自5个产区的21批无硫党参饮片的水分、总灰分、二氧化硫残留量、浸出物,分别采用原子吸收分光光度法和气相色谱法测定其重金属及有害元素、农药残留量,并采用HPLC建立党参中党参炔苷的含量测定方法.结果 21批党参饮片的二氧化硫残留不超过7 mg/kg,铅含量不超过1.124 mg/kg,砷含量不超过0.067 mg/kg,镉含量不超过0.058 mg/kg,汞含量不超过0.003 mg/kg,铜含量不超过14.121 mg/kg,总六六六含量不超过0.03 mg/kg,总滴滴涕含量不超过0.031 mg/kg,五氯硝基苯含量不超过0.008 mg/kg.党参炔苷含量测定平均加样回收率为97.71％,RSD=1.32％,平均质量分数为0.138％.结论 无硫党参饮片的安全性指标限量为二氧化硫残留不超过10 mg/kg,重金属和农药残留标准符合药典对党参饮片的限量标准,有效性指标含量测定方法可靠,可为党参的质量监控及临床使用提供依据.

目的: 通过比较现行药典中的当归质量标准和无硫加工后的当归质量, 对现行药典标准进行优化并初步构建无硫当归饮片质量标准.方法: 查阅《中国药典》 2015 版中对当归的记载, 并以"当归" "质量标准""硫熏"等为关键词, 在中国知网检索相关文献, 整理归纳.对无硫加工和平衡脱水加工后的当归饮片做质量检查.结果: 无硫加工后的当归饮片二氧化硫残留量降低, 浸出物和有效成分含量都有提高.结论: 采用无硫加工技术有利于提高当归饮片的质量, 有助于对现行药典的标准进行优化.

Chinese patent medicines for orthopedics are among the hotspot and difficulty in the rational medication of traditional Chinese medicine (TCM), because they mostly contain toxic medicinal herbs and oriented to special patients. According to the hospital pharmacy practices and the therapeutic theories of TCM, this paper focused on a novel model of rational drug use of Chinese patent medicine for orthopedics based on the principles of ″syndrome-dosage-toxicity differentiation″. We also proposed relevant specifications for guiding their clinical use. Firstly, we proposed a list of the primary clinical application characteristics for rational drug use of orthopedic TCMs, including the syndromes of patient, the dosage of medicine and the toxic ingredients in medicine. Secondly, a database was established for recording the package inserts of all of the 81 orthopedic patent medicines in our hospital, and 2 000 retrospective recipes were analyzed for looking for the high-frequency medicines and common irrational factors. Then clinical case reports involving the adverse reactions and side effects of related drugs were searched from CNKI, VIP and WanFang databases. Then the key information for rational application of each medicine was extracted from these resources and some survey questionnaires. Finally, we established a guide named instructions for clinical use of orthopedic Chinese patient medicines (ICUOCPM) after the discusstion with experts. According to the effect after the practice in hospital for 2 months, the proposed principles of ″syndrome-dosage-toxicity differentiation″ in this paper were believed to be the core elements and the most important clinical monitoring points in TCM for orthopedic patents. It would provide innovative ideas, theoretical guarantee and data support for the development of TCM clinical pharmacy.

目的:探讨中成药临床合理使用的关键要素.方法:参考《处方点评管理办法》,回顾性随机抽取某院2013年1-6月门诊中成药处方870张,开展处方点评,并分析合理用药关键要素.结果:不合格处方共171张,超剂量或超疗程用药、疹断与用药不符、药品不合理配伍、重复给药为不合理用药的四大主要因素,恰当剂量和理论指导是合理用药的关键要素.结论:以门诊一线处方为基础开展处方点评,分析中成药合理用药要素,可为深入研究中成药临床合理使用提供参考.

中药配方颗粒是指用符合炮制规范的传统中药饮片作为原料,经现代制药技术提取、浓缩、分离、干燥、制粒、包装精制而成的纯中药系列产品.2001年,当时的国家药品监督管理局将以前的"单味中药浓缩颗粒"、"配方饮片"、"中药精制颗粒"等统一命名为"中药配方颗粒".