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??OBJECTIVE To investigate Guidance for Industry Bioequivalence Recommendations for specific products issued by FDA. METHOD Combination with FDA and CFDA issued guidance related to Bioequivalence (up to May 20th, 2016), 185 FDA issued Guidance for Bioequivalence Recommendations for Specific Products were discussed, which are involved in the CFDA announced initial list of the equivalence assessment of quality and curative effect for generic products. RESULTS Bioequivalence Recommendations for Specific Products issued by FDA is to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment, as an extension and implement to the guideline involved in the aspect of bioequivalence. CONCLUSION Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since CFDA haven't released similar guidance on specific products yet.     

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??OBJECTIVE To determine two toxic impurities, namely bromoacetic acid and 4-aminobenzonitrile, in the intermediate of dabigatran etexilate by UHPLC-MS. METHODS The separation was performed on a Shimadzu Shim-Pack GIS C₁₈ column (2.1 mm??50 mm,2 ??m) with mobile phase consisting of 0.1% formic acid aqueous solution (A) and 0.1% formic acid methanol (B) by gradient elution at a flow rate of 0.4 mL??min^-1. The detection was achieved by triple quadrupole mass spectrometry with rapid polarity switching using MRM mode. RESULTS The calibration curves were linear in the ranges of 0.2-40 and 0.4-40 ng??mL^-1 for bromoacetic acid and 4-aminobenzonitrile, respectively. The values of LOQ of bromoacetic acid and 4-aminobenzonitrile were 0.1 and 0.4 ng??mL^-1, respectively. The recoveries of bromoacetic acid and 4-aminobenzonitrile were 100.9% and 99.6%, respectively. CONCLUSION The method is accurate, rapid, sensitive, and reliable to determine the two toxic impurities bromoacetic acid and 4-aminobenzonitrile in the intermediate of dabigatran etexilate for quality control.     

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??OBJECTIVE To develop an HPLC method for simultaneous determination of seven tannins in Chebulae Fructus, including gallic acid, chebulic acid, corilagin, ethyl gallate, ellagic acid, chebulagic acid and 1,2,3,4,6-O-pentagalloylglucose and determine the contents of the seven tannins in Chebulae Fructus Retz from different areas.METHODS The HPLC analysis was carried out on an Hypersil ODS2 C₁₈ (4.6 mm??250 mm,5 ??m) column with acetonitrile (A) and 0.05% formic acid solution in water (B) as mobile phase in a linear gradient elution mode. The UV detection wavelength was set at 290 nm and the flow rate was 1.0 mL??min^-1.RESULTS The calibration curves of the seven tannins all showed good linearity (r??0.999 8). The recovery rates were in the range of 95.2% to 98.4%. All the seven tannins could be detected in the two kinds of Chebulae Fructus Retz from eight regions, but the amounts of these tannins varied significantly. The contents of the seven tannins active ingredients in Chebulae Fructus of Terminalia chebula Retz from Hainan, Guangxi, Guangdong and Xinjiang were much higher than those from other areas, while those in Chebulae Fructus of Terminalia chebula Retz. var. tomentella Kurt were higher in Guangdong and Guangxi than other areas.CONCLUSION The method is proved to be accurate and valid, and can be used for the quality control of Terminalia chebula Retz.     

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?? Zingiber officinale has a long application history in China, it is used as medicine, also condiment, food and drinks. The chemical constituents of Zingiber officinale include volatile oil, gingerol,diaryl-heptnaoids and so on. Scientific research showed that Zingiber officinale is widely used in anti-nausea, resisting gastric ulcer, anti-bacterial, anti-phlogistic, analgesia, antioxidant, resisting motion sickness, anti-tumor, hypoglycemic,antilipidemic,and improving cardiocerebral vascular system and so on.Zingiber officinale is recommended as a healthy food by doctor of traditional Chinese medicine in all times. In summary, it's worth to be researched and developed in detail.     

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??Chondroitin sulfate (CS) is an anionic linear polysaccharide having natural bioactivity, which is widely utilized as a drug and nutraceutical . Due to the structure complexity and source variety of chondroitin sulfate, the specifications of chondroitin sulfate in different pharmacopoeias were different. The related references published in recent years and pharmacopeias were analyzed, sorted, and summarized. This review summarized the METHODS and limits that were used to for the assay and inspection of impurities, disaccharide and relative molecular weight of chondroitin sulfate. This article would be beneficial to improve the quality control system of chondroitin sulfate.     

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??OBJECTIVE To establish the fingerprint of Aconitum Flarum Hand. Mazz Busch. METHODS UPLC analysis was performed on ACQUITY UPLC BEH C₁₈ column(2.1 mm??50 mm,1.7 ??m). Gradient elution was conducted. Mobile A was 0.2% formic acid and 0.005% TFA in water; mobile B was methanol; and mobile C was acetonitrile. The flow rate was 0.3 mL??min^-1. The detection was carried out at 275 nm. The column temperature was maitained at 35 ??. The injection volume was 1.0 ??L. RESULTS The UPLC fingerprint of Aconitum Flarum Hand. Mazz was established, and 14 common peaks were found including the peaks of two major constituents. The similarity factors ranged from 0.850 to 0.980. In addition, there was significant difference between wild and cultivated samples. CONCLUSION This UPLC method has satisfactory precision, stability, repeatability and specificity. It provides a scientific method for identifying wild and cultivated Aconitum Flarum Hand. Mazz using fingerprint.     

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??OBJECTIVE To investigate similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration.METHODS The comparisons of these bioequivalence recommendations were performed and based on bioequivalence study designs, selection of bioequivalence subjects,dosage, selection of reference products, method of pharmacokinetic calculations and bioequivalence acceptance limits,bioequivalence waiver on multiple-strength products and and implementation of the Biopharmaceutics Classification System, which are issued by Australia, the European Medicines Association, Japan,the USA, and the World Health Organization.RESULTS There were lots of differences were found in bioequivalence approaches among the regulatory authorities surveyed, although there are more similarities.CONCLUSION Discussion of the similarities and differences among bioequivalence approaches used by international regulatory authorities would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China.     

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??OBJECTIVE To evaluate the pharmacokinetic properties and bioequivalence of two crystal forms of rifampicin. METHODS Drawing the dissolution curves of reference and test medicines in different solutions,and calculated the value of f₂. Twenty-nine healthy male volunteers were randomly administered in a crossover single 300 mg dose of reference and test medicines. Determining the concentration of rifampicin in plasma by HPLC-MS,and analyzed the relative bioavailability and bioequivalence of tablets using SAS program. RESULTS The values of f₂ were more than 50. The pharmacokinetic properties of reference and test tablets were as followsAUC_0→t:(28 476±8 050) vs (28 120±6 916) ng·mL·h^-1,ρ_max:(5 552±1 554) vs (5 911±1 700)ng·mL^-1,t_max:(2.0±1.0) vs (1.8±1.0)h,t_1/2:(2.8±0.5)vs(2.8±0.5)h. 90% CI of AUC and ρ_max of test medicine were 96.2%-106.4% and 98.6%-115.3%,respectively. And there were no significant difference of the t_max of rifampicin between the two medicines(P>0.05). CONCLUSION The results indicate that the two medicines made from rifampicin two crystal forms are bioequivalent completely.     

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??Recently, a new manner of cell death named ferroptosis is gradually accepted by researchers. It is characterized by cell death accompanied by a large accumulation of iron and lipid peroxidation. Numerous studies have shown that the manner of death are closely related to neurotoxicity, cancer, ischemia reperfusion injury, renal injury and iron metabolism related diseases,so the research of the mechanisms and regulative drugs for ferroptosis is particularly important. This paper reviewed the mechanisms, inducers, and inhibitors of ferroptosis and summarized the diseases related to ferroptosis, so that providing evidence for study the further mechanisms and development of new drugs for the ferroptosis-related diseases.     

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??OBJECTIVE To explore the active ingredients of wine fried Ligustrum lucidum fructus by studying the relationship between the HPLC chromatogram and antioxidant activity. METHODS The characteristic chromatogram of wine fried Ligustrum lucidum fructus processed by means of classical homothermal acceleration was established by HPLC. DPPH, ABTS, and FRAP METHODS were established to determine the antioxidant activity. The spectrum-effect relationship was studied by using partial least squares regression (PLSR), and the chromatographic peaks related to antioxidant activity were identified. RESULTS Peaks 1, 3, 8, 10, 14 and 15 were found to have positive relationship with DPPH free radical and ABTS free radical scavenging activity among the 17 matching characteristic chromatograms. Peaks 3, 8, 12, and 13 were significantly positively related to Fe³⁺ resuction capacity. Among the chromatographic peaks, peak 3 and peak 8 were positively related to the activities of scavenging DPPH free radical and ABTS free radical and reducing Fe³⁺. Peaks 3, 12, 13, 14, 15, and 17 were determined as salidroside, luteolin-7-O-glucoside, specnuezhenide, oleuropein, ligustroflavone, and luteolin, respectively. CONCLUSION The pharmcodynamic effects of wine fried Ligustrum lucidum fructus do not depend on the contents of several index components such as specnuezhenide and salidroside. The quality of traditional Chinese medicines should be represented by the compound groups associated with pharmcodynamic effect.     

碳纳米管的载药及安全研究进展

对碳纳米管的载药进行文献整理和分析。查阅近8年来国内外相关文献39篇。研究发现,近年来,随着药学、生物学和材料学等多学科的交叉渗透发展,人们渐渐意识到新型载药材料的应用对药物的研究具有非常重要的促进作用。碳纳米管(carbon nanotubes,CNTs)具有独特的管状结构,可有效负载和递送药物,被巧妙地用于构建独具特色的药物传输系统。虽然CNTs的载药(特别是中药)研究国内外还少见报道,但实践证明,通过表面化学修饰等手段,制备溶解性好、低毒性的功能化CNTs作为药物载体,在抗肿瘤等领域具有很好的应用前景。作者概述了近年来CNTs的载药研究(如阿霉素、盐酸表柔比星、地塞米松、两性霉素B和中药有效成分异甘草素等)及生物安全研究(包括组织毒性研究和细胞毒性研究)进展,并对CNTs的中药载药应用作了展望,以期为更多安全、可控、有效的新型递药系统的研发及相关疾病的临床治疗提供参考。     

悬钩子属植物二萜类成分及其生物活性研究进展

悬钩子属植物种类丰富、用途广泛、功效多样,具有很大的研究价值。悬钩子属植物包含多种化学成分,如萜类、黄酮类、鞣质、甾体类等,并且生物活性多样,具有抗肿瘤、抗氧化、抗炎、抗菌、调血糖、调血脂等作用。其中,萜类是悬钩子属植物能发挥多种功效的主要成分之一。总结了悬钩子属植物二萜类成分及其生物活性,以期为悬钩子属植物的进一步研究提供参考。     

微流控技术在纳米药物载体制备中的应用

微流控技术是一种在微纳米尺度空间中对流体进行精确控制和操纵的科学技术,具有将生物、化学等实验室的基本功能包括样品制备、反应、分离和检测等微缩到一个几平方厘米芯片上的能力,目前也成为纳米医药领域的研究热点之一。与传统制备纳米材料的方法相比较,微流控技术在纳米药物载体开发中具有许多优势,如能够精确控制结构、批次间重复性高、快速有效等。笔者将简要介绍微流控技术及其在聚合物纳米粒、脂质纳米粒和杂化纳米粒等纳米药物载体制备中的应用,同时也为今后研究者如何选择准确合理的微流控技术制备纳米药物载体提供思路与参考,并对其未来的发展和挑战进行展望。     

狗牙花属植物生物碱类成分及生物活性的研究进展

夹竹桃科(Apocynaceae)狗牙花属(Ervatamia Stapf)植物中的化学成分以及其生物活性一直是研究热点。其在全世界有约120种,主要分布在印度、中国西南地区,东南亚、大洋洲、北美洲、南美洲部分地区以及各海岛;在我国主要有15种和5变种,主要分布在华南地区及西南地区和台湾。我国傣族将云南狗牙花茎用于治疗产后体虚、头晕目眩、恶露淋漓等症状。据《中国植物志》中记载,产于亚洲热带与亚热带地区的单瓣狗牙花,其叶有降低血压功效,常用于治眼病、疮疥、乳疮、咬伤等;根可治头痛和骨折等。生物碱是狗牙花属植物中的主要化学成分,具有新颖的化学结构。现代药理学研究发现,狗牙花属植物中生物碱类成分具有抗肿瘤和抗乙酰胆碱脂酶等生物活性,其中抗肿瘤活性最为显著。因此狗牙花属植物具有很好的开发价值。但是,科研人员对狗牙花属植物生物碱类成分的研究仅限于发现与生物活性的测定,临床功效的研究较少。笔者结合近20年来的国内外文献对该属植物中149个生物碱进行总结,为进一步研究具有显著活性的生物碱类化学成分,合理充分利用狗牙花属植物的药用资源提供有价值的参考。     

慢性HBV与非活动性HBsAg携带者肝组织学特点与临床关系

目的：了解慢性HBV与非活动性HBsAg携带者肝组织病理学特点与年龄、HBV载量及临床的关系。方法：对符合慢性HBV携带者（69例）与非活动性HBsAg携带者（77例）诊断标准的146例行肝穿刺活组织学检查,判断肝组织炎症活动（G）、肝纤维化（S）分级、分期。结果：146例中〉G0～〈G18例,G178例,G253例,G37例,分别为5．5％、53．4％、36．3％与4．8％,无GO;SO112例,S127例,S25例,S32例,分别为76．7％、18．5％、3．4％与1．4％。G、S分级、分期严重程度与年龄增长呈正相关,有统计学意义。慢性HBV携带者肝组织病理学改变与血清HBVDNA载量无关。慢性HBV与非活动性HBsAg携带者肝组织病理学改变比较无统计学差异。结论：慢性HBV与非活动性HBsAg携带者肝组织结构均存在不同程度损害,严重程度与年龄增长正相关,与HBV载量无固定关系。建议对HBVDNA定量〉检测值慢性乙肝患者扩大抗病毒治疗范围,防止肝脏不良事件（肝硬化、肝癌）发生。     

前非离子体的研究进展

查阅了近10年国内外相关文献,对前非离子体的性状、制备、药物包封率以及应用进行综述。前非离子体的性状主要有半固体液晶凝胶和干颗粒散剂2种;制备方法主要有悬浮法、缓慢喷雾包衣法、凝胶相分离法;影响药物包封率的因素主要有非离子表面活性剂的种类及含量、胆固醇及卵磷脂的含量和水溶性介质的pH等;应用于难溶性药物、非甾体抗炎药、激素类药物、抗高血压药、抗炎止痛药、脑血管扩张药、抗过敏药等。但目前对前非离子体的研究主要停留在实验室阶段,在作用机制和临床治疗方面都需要深入探索。     

产后抑郁的生物学机制研究进展

产后抑郁是指产妇分娩后4周内发生的抑郁症,对产妇的身心健康和婴儿的智力、情绪、思维等产生消极影响。由于对产后抑郁的重视度不高以及缺乏有效药物,导致该病的发病率和患病率逐年升高。近年来研究发现,产后抑郁的生物学机制主要与神经递质失调、神经内分泌紊乱以及炎症介质过度释放等密切相关。中医药治疗产后抑郁疗效确切,然而其作用机制尚不清晰,因此,笔者综述近年来国内外学者对产后抑郁症的生物学机制研究成果,旨在为中医药治疗产后抑郁症的临床及基础研究提供思路。     

木兰科含笑属萜类成分及其生物活性研究进展

对木兰科含笑属植物的分布、萜类成分、生物活性等方面的研究作了综述；并根据萜类成分的结构按其所属的基本骨架进行了分类整理，为含笑属药用植物的系统分类提供有价值的化学依据，并为全面评价该属植物的药用价值提供参考。     

藁本属萜类及其生物活性研究进展

对伞形科藁本属的分布、萜类成分、生物活性等方面的研究进行了综述;并根据萜类成分的结构按其所属的基本骨架进行了分类整理,为藁本属药用植物的系统分类提供有价值的化学依据,并为全面评价该属植物的药用价值提供参考。     

山胡椒属萜类及其生物活性研究进展

对山胡椒属植物的分布、萜类成分、生物活性等方面的研究作了综述;并根据萜类成分的结构按其所属的基本骨架进行了分类整理,为山胡椒属药用植物的系统分类提供有价值的化学依据,为全面评价该属植物的药用价值提供参考。