对《中华人民共和国药典》2020版一部所收载的处方中含冰片、薄荷或其加工品的成方制剂进行了统计,共305种,占一部成方制剂总量的18.98％.针对成方制剂中冰片、薄荷质量控制情况,分别对鉴别方法、含量测定方法进行了总结,发现两者的质量控制均以薄层色谱法鉴别、气相色谱法含测为主,方法较为成熟但也存在制剂中未对两药进行质量控制的情况.对含冰片、薄荷的中药成方制剂收载品种情况、入药方式、鉴别检查、含量测定及注意事项等内容进行分类统计,总结冰片、薄荷质量控制的现状、规律和不足,以期为含冰片、薄荷的中药成方制剂质量全面控制提供参考和借鉴.

重楼作为我国传统的名贵中药材,主要分布在云南、广西、贵州等西南一带,具有清热解毒、消肿止痛、凉肝定惊的功效,治疗铁打伤痛、毒蛇咬伤、凉风抽搐等具有奇效,迄今已经有2 000多年的应用历史.重楼皂苷Ⅱ结构上属于薯蓣皂苷,是重楼的主要活性成分之一,具有抗肿瘤、抗炎、抗病毒、抗菌、免疫调节、抗氧化、逆转多药耐药等多种药理活性,展现出良好的应用前景.其中,重楼皂苷Ⅱ的抗肿瘤作用受到广泛关注,其作用机制与抑制增殖、迁移和侵袭,诱导细胞周期阻滞、凋亡和自噬,抑制血管生成,调节肿瘤微环境等有关.药代动力学显示,重楼皂苷Ⅱ由于其溶解度低、吸收差、体内分布不理想、代谢慢等因素,导致其体内生物利用度低,严重限制其临床应用.近年来,重楼皂苷Ⅱ的不良反应报道增多,如具有较强的溶血活性,并对肝、肾、心肌、心血管细胞等产生明显细胞增殖抑制作用.以"重楼皂苷Ⅱ""Polyphyllin Ⅱ""Paris Saponin Ⅱ"为主要关键词,通过检索"中国知网""维普""万方""PubMed""Web of Science""Elsevier SD"等中英文数据库,现从药理作用及其机制、药代动力学研究、不良反应3个方面对其研究进展进行综述,以期为重楼皂苷Ⅱ的深入研究和开发利用提供思路和参考.

As arsenic widely exists in nature and has been used in the pharmaceutical preparations, the traditional Chinese medicine(TCM) with arsenic include realgar(As_2S_2 or As_4S_4), orpiment(As_2S_3), and white arsenic(As_2O_3). Among the above representative medicine, the TCM compound formulas with realgar are utilized extensively. Just in Chinese Pharmacopoeia(2020 edition), there are 37 Chinese patent medicines including realgar. The traditional element analysis focuses on the detection of the total amount of elements, which neglects the study on the speciation and valence of elements. The activity, toxicity, bioavailability, and metabolic pathways of arsenic in vivo are closely related to the existence of its form, and different forms of arsenic have different effects on organisms. Therefore, the study on the speciation and valence of arsenic is of great importance for arsenic-containing TCMs and their compound formulas. This paper reviewed four aspects of the speciation and valence of arsenic, including property, absorption and metabolism, toxicity, and analytical assay.

作为名贵中药材,麝香、牛黄常用于急重症患者的救治,但因二者来源稀缺、价格昂贵,野生动物资源急需保护,天然麝香和牛黄已经无法满足制剂生产的需要,人工麝香、人工牛黄、体外培育牛黄等代用品的使用在一定程度上缓解了原药材紧张的问题,目前已被广泛用于中药制剂的生产和使用.2020年版《中华人民共和国药典》(以下简称《中国药典》)共收载了 75个中药制剂含有麝香,95个制剂含有牛黄,但在这134个中药制剂的质量标准中,对天然药材与其代用品的区别并不十分明显,部分质量控制项目较为简单.笔者通过梳理2020年版《中国药典》(一部)所载含麝香、牛黄的中药制剂的质量标准情况,包括制剂中麝香或牛黄的类型、入药形式、处方用量、每日(次)最大服用量及质量控制项目等,探讨含麝香、牛黄的中药制剂质量标准的合理性,并在规范麝香和牛黄的使用类型、结合现代研究成果和先进技术完善中药制剂中麝香、牛黄的质量控制项目等方面给出建议,以期能够科学认识、评价含有麝香和牛黄的中药制剂,并为此类中药制剂的质量标准提高提供参考.

目的 优化五味子的提取纯化工艺参数,得到较高含量的五味子总木脂素;并经制剂处方工艺优化,制备得到载药量高、稳定性良好的微乳制剂.方法 采用回流提取、大孔树脂柱洗脱相结合的方法,对五味子木脂素成分进行富集;建立高效液相色谱法,以五味子醇甲等8种成分为指标,考察五味子提取物中总木脂素的含量,明确不同环节的成分转移率;采用超声乳化法制备五味子木脂素微乳,并通过单因素考察,对制剂处方和工艺进行研究.结果 建立的8种木脂素成分同时测定的方法专属性、准确性和精密度等方法学考察均符合要求;五味子提取物总木脂素含量为60.85％,其中五味子醇甲等8种木脂素成分总含量为44.57％;以大豆油为油相,吐温-80为表面活性剂制备微乳,微乳的平均粒径为248.3nm,平均载药量为2.44mg·mL-1,pH值为6.5.结论 建立的五味子提取物中8种成分同时测定方法准确可行,可用于其质量控制;提取纯化得到的总木脂素含量较高、重复性良好;制备的五味子微乳载药量较高、粒径均匀、稳定性良好,可为五味子总木脂素的进一步研究奠定基础.

Metal-organic frameworks (MOFs) are porous coordination polymers formed by metal ions and organic ligands through coordination bonds. In drug delivery applications, MOFs can impart sustained release, targeting, protection of easily degradable drugs, and improved drug solubility. Isoreticular metal-organic framework-8 (IRMOF-8) is a mesoporous MOF with a network topology bridged in the form of an octahedral cluster. Compared with other materials, it has the remarkable advantages of high porosity and a regular pore structure. Curcumin (CUR) is a diketone compound with potent antitumor effects. Due to its poor solubility and stability, its clinical application is limited. Therefore, we used IRMOF-8 as a carrier for the encapsulation of CUR to overcome the shortcomings of CUR itself and expand its clinical application. In this study, IRMOF-8 was synthesized through direct mixing of triethylamine (TEA). In vitro cell experiments demonstrated the biocompatibility of IRMOF-8. Using the solvent adsorption method, CUR was encapsulated by IRMOF-8 with a drug loading content of 58.86 +/- 0.98 wt%. In vitro drug release experiments performed at pH levels of 7.2 and 5.5 showed that the preparation had a sustained-release effect over 7 days. Through cytotoxicity experiments after drug loading, it was found that CUR@IRMOF-8 had a strong cytotoxic effect on HepG2 cells, promoted cell apoptosis and intracellular uptake, decreased mitochondrial membrane potential, and increased reactive oxygen species. Hence, CUR@IRMOF-8 is expected to become an excellent sustained-release preparation for potential applications in tumor treatment.

In this study, the critical quality attributes of Wuzhuyu Decoction reference sample were explored by using characteristic chromatogram, index component content and dry extract rate as indexes.The dissemination relationship of quantity value between medicinal materials-decoction pieces-reference sample was investigated to preliminarily formulate the quality standard of the reference sample.The characteristic chromatogram of 15 batches of Wuzhuyu Decoction was established by high performance liquid chromatography(HPLC) and the similarity analysis was conducted.Common peaks were demarcated and assigned to medicinal materials.Moreover, quantitative determination of limonin, evodiamine, rutaecarpine and ginsenoside Rb_1 of Wuzhuyu Decoction were performed.The dissemination of quantity value was explored combined with dry extract rate, similarity of characteristic chromatogram and transfer rate of index component content.A total of 18 common peaks were identified in the corresponding materials of Wuzhuyu Decoction reference sample, with the similarity of characteristic chromatogram greater than 0.9, and Fructus Evodiae, Radix Ginseng, Rhizoma Zingiberis Recens and Fructus Jujubae contributed 9, 5, 8 and 2 chromatographic peaks, respectively.The index component content of corresponding materials and the transfer rates of medicinal materials-decoction pieces and decoction pieces-reference sample of different batches of Wuzhuyu Decoction reference sample were as follows: the content of limonin was 0.16%-0.51%, and the transfer rates were 83.66%-115.60% and 38.54%-54.58%, respectively; the content of evodiamine was 0.01%-0.11%, the transfer rated were 80.80%-116.15% and 3.23%-12.93%, respectively; the content of rutaecarpine was 0.01%-0.05%, the transfer rates were 84.33%-134.53% and 5.72%-21.24%, respectively; the content of ginsenoside Rb_1 was 0.06%-0.11%, and the transfer rates were 90.00%-96.92% and 32.45%-67.24%, respectively.The dry extract rate of the whole prescription was 22.58%-29.89%.In this experiment, the dissemination of quantity value of Wuzhuyu Decoction reference sample was analyzed by the combination of characteristic chromatogram, index component content and dry extract rate.A scientific and stable quality evaluation method of the reference sample was preliminarily established, which provided basis for the subsequent development of Wuzhuyu Decoction and the quality control of related preparations.

目的:系统评价复方苦参注射液联合化疗方案治疗非小细胞肺癌的有效性和安全性.方法:计算机检索PubMed、EMBase、the Cochrane Library、中国期刊全文数据库、中文科技期刊全文数据库、万方数据库及中国生物医学文献数据库等数据库,全面收集复方苦参注射液联合化疗方案治疗非小细胞肺癌的随机对照试验(观察组患者采用复方苦参注射液联合化疗方案,对照组患者仅采用化疗方案),按纳入与排除标准选择文献,进行方法学质量评价并提取资料,采用RevMan 5.3软件进行文献荟萃分析(Meta分析).结果:最终纳入19篇文献,共1539例患者.Meta分析结果表示:观察组患者的临床总有效率(RR=1.43,95％CI=1.27～1.61,P<0.00001)、生活质量改善情况(RR=1.54,95％CI=1.38～1.72,P<0.00001)明显优于对照组,白细胞减少发生率(RR=0.73,95％CI=0.66～0.79,P<0.00001)、胃肠道反应发生率(RR=0.70,95％CI=0.64～0.76,P<0.00001)明显低于对照组,差异均有统计学意义.结论:复方苦参注射液联合化疗方案可以提高非小细胞肺癌患者的临床总有效率,改善患者生活质量,减少不良反应发生.但本研究的结论尚需更多严谨的多中心、大样本的随机双盲对照试验加以证实.

目的:系统评价鸦胆子油乳注射液联合化疗方案治疗非小细胞肺癌的临床疗效及安全性.方法:计算机检索中国期刊全文数据库、中文科技期刊全文数据库、中国生物医学文献服务系统、中国生物医学文献数据库、万方数据库、PubMed、EMBase及the Cochrane Library等数据库,纳入鸦胆子油乳注射液联合化疗方案治疗非小细胞肺癌的随机对照试验(观察组患者采用鸦胆子油乳注射液联合化疗方案,对照组患者仅采用化疗方案),采用Cochrane风险评价表评价其方法学质量,提取资料并采用RevMan 5.2软件进行文献荟萃分析(Meta分析).结果:最终纳入18篇文献,共1419例患者.Meta分析结果显示,观察组患者的临床疗效明显优于对照组(RR=1.21,95％CI=1.10～1.34,P=0.0002),生活质量改善情况明显优于对照组(RR=1.85,95％CI=1.62～2.12,P<0.00001),差异均有统计学意义.观察组患者白细胞减少发生率明显低于对照组,差异有统计学意义(RR=0.72,95％CI=0.65～0.80,P<0.00001);但两组患者胃肠道反应发生率的差异无统计学意义(RR=0.88,95％CI=0.75～1.02,P=0.08).结论:鸦胆子油乳注射液联合化疗方案治疗非小细胞肺癌,可以显著提高患者临床总有效率,改善患者生活质量,降低白细胞减少发生率.但本研究结论尚需更多设计良好的多中心、大样本随机双盲对照试验加以证实.

本文对《中国药典》2020版一部“药材及饮片”部分和“中成药”部分收载的矿物药、含矿物药中成药的品种、性状、鉴别、检查、含量测定等方面的内容进行了总结与分析。根据矿物药中含有的阳离子种类（汞、钙、镁、钠、铁、砷、铝及其他8类）将含矿物药的中成药进行分类统计，包括对矿物药的入药方式、鉴别检查、含量测定以及毒性矿物药用法用量、注意事项等方面，分析了含矿物药的中成药的质量标准控制的现状和不足，整理了“药材及饮片”部分中未收载但中成药处方中含有的矿物药品种（9种），希望能够为进一步丰富《中国药典》中收载的矿物药品种提供参考。通过以上内容的分析，希望能够全面地了解《中国药典》2020版一部中矿物药、含矿物类中成药的质量控制现状，为矿物药的全面质量控制提供借鉴，为更加科学、完整地评价矿物药、含矿物药中成药提供参考。