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??OBJECTIVE To describe the continuous improvement process of the quality system of phase I labs by using(plan-do-check-action) PDCA method. METHODS Considering the particular characteristics of phase I labs, PDCA cycle was applied to the quality management system as well as the research programs. RESULTS As a quality management tool, PDCA method holds the same goal as ISO 17025 system, that is, to improve the management system of phase I labs. CONCLUSION PDCA method is very useful in helping phase I labs achieve the quality goals, which, as a result, can ensure the accuracy and reliability of the research results.     

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??The current prevalence of cancer chemotherapy drugs is inefficient and highly toxic, thus selecting the appropriate new forms of cancer treatment has become one of the important tasks. On the basis of domestic and foreign research literature, cutline the composition, characteristics and main preparation methods of polymeric micelles. Introduced varieties of stimuli-responsive polymer micelles, as well as targeted polymeric micelles used as an anticancer drug carrier. By making use of inside microenvironment of tumor cells, the preparation of various of new intelligent polymeric micelles with slight side effects and good treatment in virto and in vivo, can achieve effective control of drug release, which has great development and prospect in application.     

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??Stimuli-responsive nano drug delivery systems based on specific structures and physicochemical properties of tumor have been drawing wide attention from researchers, one of which is charge-reversal nano drug delivery system(CRN-DDS). CRN-DDS can effectively combine the merits of positive and negative charges in the drug delivery process in vivo, and it also has the good property of tumor-targeting.Although studies of CRN-DDS application in cancer therapy have already been reported, there is very little relevant Chinese literature, especially review articles.To fill in the blank, the foreign literatures about CRN-DDS were looked up in the last six years,classified CRN-DDSs by their different approaches of surface charge reversal, and summarized the studies on their applications in the cancer therapy. Last but not least, the prospect of CRN-DDS??s development and application was preliminarily looked into in this article.     

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??OBJECTIVE To establish a method for the quality control of Lonicerae Japonicae Flos by multi-components quantitative fingerprint. METHODS Chlorogenic acid was selected as the marker of ingredients to establish the HPLC fingerprint and as the internal reference standard to determine the contents of other eight components(neochlorogenic acid, cryptochlorogenic acid, chiratin, rutin, galuteolin, isochlorogenic acid B, isochlorogenic acid A and isochlorogenic acid C) according to the relative correction factor of quantitative analysis of multi-components by single marker(QAMS) by slope correction method. At the same time, the nine components were determined by external standard method. The accuracy and feasibility of QAMS were evaluated by comparison of the results between external standard method and QAMS. RESULTS The fingerprint of Lonicerae Japonicae Flos was established, 21 common peaks were identified in all the tested samples, nine of which were verified, the similarities of 20 batches of Lonicerae Japonicae Flos samples were in the range of 0.959-0.997, and there was no significant difference between the quantitative test results of nine ingredients in 20 batches by the QAMS method and external standard method. CONCLUSION The method of multi-marker components quantitative fingerprint is feasible and accurate for the quality control of Lonicerae Japonicae Flos, and it might be a new quality evaluation pattern for Traditional Chinese medicine.
     

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??OBJECTIVE To explore the application value of microflow digital imaging (MDI) in sub-visible particle detection of monoclonal antibodies(mAbs). METHODS Polystyrene latex particles were adopted as standard particles to evaluate the stability and accuracy of MDI, then MDI was used to detect the quantities and compositions of sub-visible particles with diameters of ≥10 μm and ≥25 μm in two groups of mAbs. One group containing three mAbs from different companies against EGFR was selected to show the compositional difference of sub-visible particles. Another group was set to evaluate the impact of storage conditions on stability of sub-visible particles in mAb against TNF-α. The storage conditions included 4 ??,37 ?? and exposure under light of 6 000 lx. RESULTS Using polystyrene latex particles, MDI method showed acceptable stability and accuracy. The analysis showed that the numbers of sub-visible particles in mAbs from Company 1 and Company 2 were comparable, but their main compositions were non-protein and protein particles separately. The number of sub-visible particles in mAb from Company 3 was much higher than that of Company 1 and Company 2 and the sub-visible particles included both non-protein and protein particles, indicating differed strategies should be adopted to control sub-visible particles. It was also found that the selected antibody against TNF-α was much more unstable when stored at 37 ?? or exposed under light of 6 000 lx as the quantities of protein particles were increased dramatically, which suggested the obvious impact of storage conditions on stability of protein in mAbs. CONCLUSION MDI can provide not only diameters and the quantities of sub-visible particles, but also morphological information and tell the nature of the particles. These functions are powerful tools for sub-visible particle control and quality evaluation of mAbs.     

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??As a model organism, Drosophila melanogaster has the characteristics of short life cycle, high fecundity and high gene conservation. At present, Drosophila melanogaster has been widely used in the studies of pharmacology and pathogenesis, including aging, neurodegenerative disease, insomnia, tumor and other fields, which show potential values in accelerating the speed of drug screening and target discovery. In this paper, the advantages of Drosophila as a model organism, the applications and limitations of Drosophila in pharmacological studies were reviewed.     

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??Poly(2-oxazoline)s (POx) have the same repeated C-C heteroatomic chains, which is very similar to polyethylene glycol (PEG), so POx have the similar properties to PEG, such as hydrophilicity and flexibility and low immunogenicity, etc. However, POx also possesses pH-sensitivity, thermo-responsibility, and does not interfere with the cellular uptake of nanocarriers, which highlights the potential of POx as an ideal alternative to PEG for constructing and modifying liposomes, micelles, polymer-drug conjugates and other nanocarriers. Among the POx, the chemical nature of poly(2-ethyl-2-oxazoline) (PEOZ) is the most active, which is the most widely used. In this paper, the synthesis of POx serial derivatives and their application in drug delivery systems were reviewed, mainly focused on PEOZ.     

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??OBJECTIVE To explore a practical method for isolation of mitochondrial DNA from Fetus Cervi and set up an accurate method to distinguish Fetus Cervi from adulterants. METHODS The improved SDS alkaline lysis and salt-outing METHODS were used to extract mtDNA and genomics DNA from Fetus Cervi and fetus from adulterant animals respectively. A set of primers were designed by bioinformatics to establish PCR system and reaction which could be used to identify Fetus Cervi species. RESULTS The mtDNA extracted from Fetus Cervi by improved SDS alkaline lysis method had high content and purity, which met the PCR response requirements. There was a pair of primers which could distinguish Fetus Cervi from adulterants. CONCLUSION Extraction of mtDNA by improved SDS alkaline lysis method is practical and accurate. The distinctive PCR can distinguish Fetus Cervi from adulterants and counterfeit animal fetus and it is accurate and reliable.     

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??OBJECTIVE To establish an LC-MS/MS method for the determination of levetiracetam to investigate the pharmacokinetics of levetiracetam extended-release tablets at fasted and fed states. METHODS The separation was achieved on a Waters Symmetry C₁₈ column (3.9 mm??150 mm,5 ??m) with mobile phase consisting of acetonitrile-5 mmol??L^-1 ammonium acetate and 0.3% formic acid aqueous solution (10/90, V/V). Two subjects were randomly assigned to receive single oral dose of levetiracetam extended-release tablets 1 000 mg after being fasted and fed by a randomized crossover design. The plasma concentrations of levetiracetam were measured by LC-MS/MS. RESULTS The calibration curve of levetiracetam in human plasma was linear over the concentration rang of 0.100 0-80.00 ??g??mL^-1. Under fasted and fed conditions, the main pharmacokinetic parameters of levetiracetam were as follows:??_max were 20.50 and 19.09 ??g??mL^-1, AUC_{0-48 h} were 345.4 and 336.3 ??g??h??mL^-1, t_max were 4.5 and 7.0 h, respectively. CONCLUSION The method is proved to be convenient, accurate and sensitive, and suitable for the pharmacokinetic study of 1 000 mg levetiracetam extended-release tablets in healthy Chinese volunteers after being fasted and fed. The result suggests that high fat and calories diet has effect on the pharmacokinetics of levetiracetam extended-release tablets, with t_max being delayed.     

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??This review introduced the structural characteristics, drug carrier materials,preparation and exosyndrome of cubosomes. The authors mainly analyzed the advantages, prospect and existing problems of cubosomes as apotential drug delivery system for transdermal administration to provide a reference for further development of cubosomes as a drug delivery system for transdermal administration.     

醇质体在经皮给药方面的应用

对一种新型经皮给药载体——醇质体进行综述研究分析.根据近10年国内外文献,总结醇质体的制备方法、性质、促透机制及应用进展.醇质体性质稳定,制备简单,包封率高,适用于各种性质的药物,与普通脂质体相比,显著提高了透皮速率,能传递药物至皮肤深层,增加药物在皮肤深层的滞留量.醇质体的制备工艺简单,可以包载各种类型的药物(包括水溶性、脂溶性、两亲性以及蛋白多肽类),并能达到较高的包封率.与普通脂质体相比,醇质体可以携带药物到达皮肤深层,并提高其经皮吸收速率;与传递体相比,醇质体更稳定;醇质体还可制成凝胶、贴剂、乳膏等方便临床用药的制剂,因而在局部用药和药物经皮吸收方面具有很好的应用前景.     

新型载体经皮凝胶剂的研究进展

目的:对几种新型载体在经皮凝胶剂中的研究与应用进行文献整理和归纳。方法:通过查阅近20年经皮凝胶剂的相关文献,阐述几种新型载体的含义、特点及其凝胶剂经皮给药的实验性研究,比较它们与其他剂型经皮吸收的效果,归纳总结了几种新型载体凝胶经皮给药的研究近况,并提出了其在中药复方凝胶剂中的应用思路。结果:新型载体凝胶剂相对于普通凝胶剂及其他经皮给药剂型,有更强的渗透皮肤能力,能提高药物的稳定性,具有缓释性和靶向性。结论:目前,新型药物载体在经皮凝胶剂中的运用主要集中在几种常用载体和治疗皮肤疾病的药物上,随着研究的深入,必将拓宽到更多的新型药物载体和治疗非皮肤疾病的药物。新型载体凝胶剂给改善中药复方外用制剂带来启发和思考并有望在中药复方新剂型中得到应用。     

微针在经皮给药领域的研究进展

 目的阐述近年来微针技术应用于经皮给药的最新进展。方法查阅近年来有关微针技术发展的代表性文献,并对其归纳总结。结果和结论将微针技术用于经皮给药具有很多优势,随着其安全性研究的逐步深入和相关标准的统一,微针将成为一类新型的经皮给药方式。     

柔性脂质体在中药经皮给药制剂中的应用

介绍2种能增加药物透皮吸收的柔性脂质体:传递体和醇质体。对它们的特点、机制及在中药经皮给药制剂中的应用实例进行了介绍。这2种新型脂质体能增加中药有效成分的透皮吸收,有良好的应用价值。     

透皮给药载体微乳的研究进展

 目的综述近年来透皮给药载体微乳的国内外研究进展,为其开发和应用提供参考。方法通过调研国内外文献,较全面地介绍微乳作为透皮给药载体的研究现状及发展趋势。结果与结论微乳作为透皮给药载体具有独特优势,虽然目前仍存在一些问题,但通过研究的不断深入,其在透皮给药领域将有更广阔的发展前景并将得到广泛应用。     

蒙医传统疗术药物外用法与透皮给药系统

蒙医传统疗术药物外用法和透皮给药系统均属于外治疗法，具有简、便、验、廉且可以避免肝脏首过效应等优点。药物通过皮肤屏障现代医学多采用透皮吸收促进剂、离子导入等方法促使药物穿透皮肤；蒙医传统疗术药物外用法以引病外除、整体观及辨证施治等蒙医基础理论为指导，常采用活血化瘀、促进气血运行蒙药，并与热因子、机械力因子等物理因子和穴位给药相结合，有利于皮肤吸收。蒙医传统疗术药物外用法为天然药物自然疗法，正在受到人们的重视和关注。近年来蒙医传统疗术药物外用法正在利用透皮给药系统等现代科学手段进行研究和逐步提高，尤其是有机结合物理因子和穴位给药为蒙医传统疗术药物外用法优势所在，其内容丰富，具有奇特的临床疗效，值得我们深入研究。     

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??Microneedle-based transdermal drug delivery system refers to the use of microneedles piercing the stratum corneum of the skin to form tiny pores, through which drug absorption via the skin is enhanced with minimal pain sensation. As a novel drug delivery method, the microneedle technology can significantly improve the transdermal absorption efficiency of the drugs, especially hydrophilic drugs, as compared with using transdermal drug formulations alone. Thus the scope of applicable drugs for transdermal delivery are remarkably enlarged, the efficacy and bioavailability improved as well. Microneedle technology has developed rapidly in the field of transdermal drug delivery. In this paper, the recent representative literature on microneedle-aided transdermal drug administration home and abroad to present the latest progress in this field that was summarized.     

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??Transdermal drug delivery offers a number of advantages including improved patient compliance, sustained release, avoidance of gastric irritation, as well as elimination of pre-systemic first-pass effect. However, the skin barrier function limits the transdermal penetration of macromolecular drugs.Microneedle arrays can remarkably increase the skin permeability for drugs, especially macromolecular drugs, by forming microchannels in the skin. In recent years, the types and usages of microneedle have made great progress. This review focuses on remarking the wound repair and pharmacology evaluation, as well as introduces the microneedle percutaneous drug delivery system.     

透皮给药制剂中辅料的应用

众所周知,药用辅料是制剂存在的物质基础,随着医药科技的不断发展,药物制剂不断向高效、速效、长效和服用剂量小、毒副作用小的方向发展,药物剂型也向定时、定位、定量的给药系统不断转化,制剂质量有了大幅度提高.     

非那甾胺醇质体和脂质体的经皮渗透比较研究

 目的比较醇质体与脂质体作为非那甾胺经皮传输载体的给药特性。方法制备非那甾胺醇质体和脂质体,用透射电镜观察它们的形态,测定其粒径、电位、包封率及载药率等参数,并用人皮进行体外经皮渗透研究。结果非那甾胺醇质体和脂质体粒径分别为(92±4.0)和(129±6.1)nm,两者的表面荷电性相反。醇质体的包封率与脂质体接近,但是前者的载药率是后者的6倍多。醇质体的经皮渗透速率(1.34μg·cm^-2·h^-1)是脂质体的3.2倍;24 h时药物在皮肤中滞留量为醇质体(24.3±3.0)μg·cm^-2比脂质体(9.7±1.1)μg·cm^-2,药物在表皮层和真皮层的分布比例呈明显的倒置现象。结论醇质体与脂质体相比较,能显著促进非那甾胺的经皮吸收,而脂质体在减少全身吸收、突出局部疗效有一定优势。