中药注射剂荧光光谱法的快速鉴别和热稳定性研究

红外光谱指纹图谱技术应用中药注射剂的快速鉴别中，某些试样因难于成膜造成制样困难，为此，直接或仅经水稀释后测定了12种21批次的常用中药注射剂的荧光光谱。结果表明：由于中药注射剂常含荧光性物质，但因不同注射剂所含具体荧光性物质不同，同种注射剂又因厂家的具体配方的差异或制备工艺条件的波动，均会使其特征的荧光激发、发射光谱不同或其强度呈现差异；从而可充分利用荧光分析的高灵敏度，使其作为中药整体红外指纹识别的一种辅助手段，根据注射剂的荧光图谱的差异达到快速鉴别、认定和控制配方、工艺的目的。比较而言，荧光法表现出来的差异更为一目了然，易于判断。此外，荧光光谱法还可用于中药注射液的热稳定性的研究。     

2010年版中国药典编制完成 增加900多种中药

国家药监局不久前宣布,2010年版《中国药典》已经编制完成,将于明年7月1日实施。新版《中国药典》分为中药、化学药、生物制品3部,收载品种4600余种,其中新增1300余种,基本覆盖国家基本药物目录品种和国家医疗保险目录品种。据介绍,新版《中国药典》关注药品安全性,除在附录中加强安全性检查总体要求外,在品种正文标准中也大幅增加或完善安全性检查项目,进一步提高对高风险品种的标准要求,进一步加强对重金属或有害元素、杂质、残留溶剂等的控制,并规定眼用制剂按无菌制剂要求。新版药典对高风险药品尤为重视,增加了化学药注射剂安全性检查法应用指导原则;在制剂通则中将渗透压摩尔浓度检查作为注射剂的必检项目;对药典一部收载的中药注射剂品种全部增加了重金属和有害元素限度标准;此外对于其它注射剂品种的标准也不同程度地增加了对产品安全性、有效性及质量可控性等方面的质控要求。这些措施对于解决注射剂、特别是中药注射剂的安全性问题必将起到积极的作用。新版药典收载中药材、中药饮片、中成药和中药提取物标准大幅提升。新版药典共收载了2136个中药品种,比原来增加了900多种。在中药附录中加强安全性检查总体要求,在中药正文标准中增加或完善安全性检查...     

中药指纹图谱共有峰的自动识别

依托时间匹配、光谱信息辅助,利用自编的VB程序,建立并比较了时间匹配和时间匹配参考光谱信息两种识别中药指纹图谱共有峰的方法,并成功地应用于肉苁蓉的高效液相色谱-二极管阵列检测器(HPLC-DAD)法指纹图谱的建立.结果表明,只需要人为设置色谱峰大小下限、保留值相对误差上限和最大吸收波长差值上限三个参数,VB程序编制的指纹分析系统就能快速对所有样本进行共有峰识别和模糊数学处理,实现了无人工干预下的中药指纹图谱共有峰的自动识别,指纹图谱的建立过程客观,并且节省大量时间,其中参考光谱法识别结果更准确.     

基于自组织映射神经网络的中药注射剂质量快速鉴别方法

将近红外光谱分析技术与人工神经网络相结合,研究提出一种基于自组织映射神经网络的近红外光谱神经元分类模型,用于对中药注射剂产品的近红外光谱进行计算分析,可实现对注射剂质量的快速鉴别。以3个不同厂家生产的参麦注射剂为研究对象,考察本方法的分类能力,其分类正确率达到96.4%,优于参与比较的判别式偏最小二乘法(90.5%)、反向传播神经网络(88.1%)和支持向量机(90.5%)。     

固相微萃取-气相色谱法测定醒脑静注射剂中的麝香酮

中药制剂醒脑静注射剂中的麝香酮含量较低,采用水蒸气蒸馏法需要长时间的提取富集才能进行含量测定.本文采用固相微萃取-气相色谱法（SPME-GC）对醒脑静注射剂中的麝香酮含量进行测定,集样品采集、萃取、浓缩、进样和分析于一体,完成测定的整个过程仅需十几分钟,操作简单,测定结果准确可靠.     

荧光光谱法对中药注射液热稳定性的研究

采用荧光光谱法对中药注射液热稳定性进行了初步探讨。发现在恒温（40℃、80℃）条件下、不同中药注射液随时间变化的荧光强度和荧光谱图，呈现出类似规律性的变化，但又有各自的特点。通过对其谱图和荧光强度的分析，能够反映出中药注射液在受热条件下，随时间变化的荧光谱的差异，不同温度对谱峰强度的差异性影响及不同注射剂热稳定性变化曲线的差异，从而提示中药注射液受热变质中组分变化的一些特点。找出了不同温度下不同中药注射液荧光强度减弱10％的时间。     

七种无机元素与中药药性的相关性研究

本文研究支持向量机用于中药药性识别的可行性.选择7种无机元素在中药中的含量为指标,运用支持向量机对193种不同药性的中药进行训练,建立平性与非平性中药的预测模型.结果训练集识别正确率95.03%,建立的模型对预测集中平性药的识别正确率为82.14%,对非平性药的识别正确率为70%,总正确率为73.58%.     

Chem Base:一个包含化学成份的中药资料库

一个用多媒体技术开发的中药资料库ChemBase已经完成,它可用作收集和提取中药信息。ChemBase主要由CMBASE及CHIMED两个程序组成。CMBASE用来储存中药的资料,除了该中药的基本资料外,其他大部分中药资料库都没有的一些资料,例如化学鉴定方法和化学成份等都包含在内。用户还可以随意增减有关中药的记录。CHIMED是一个界面程序,它令ChemBase更简单易用。此外,ChemBase提供了一个可连接到其他有关中药站点的网页,使用户可以通过互联网轻松地找到更多中药的资料。     

中药配伍的统一分析方法研究Ⅰ.单味药与复方的分离、特征组分的识别以及指纹对比

 中药配伍是传统中药理论之一 ,其物质分析是中药基础理论现代化研究的重点。中药配伍的特点是物质组分复杂、多变和整体性强 ,因此单一或少量组分的分析结果很难表征药物的性质。采用反相液相色谱模式 ,以黄芪、当归以及自制的“当归补血汤”的分离、特征组分识别以及指纹对比的实例分析 ,介绍了中药配伍分析的多模式多柱色谱系统以及统一分析方法的研究思路。     

近红外光谱法最小二乘双胞胎支持向量机的应用研究

依据中药大黄的近红外光谱信息,采用最小二乘双胞胎支持向量机( LSTSVM)算法,通过MATLAB软件编程,建立参数可优化识别模型,实现了对中药大黄的真伪鉴别.将实验材料98个大黄样品随机划分为训练集和测试集,对于训练集60个样品采用留1/5法交叉验证优化模型参数,以所选最优化参数结合训练集样品的近红外光谱建立最优识别模型,对测试集的38个样品的真伪迸行识别,识别率可达97.4％.结果表明,LSTSVM算法是一种有效的识别方法,可依据中药大黄的近红外光谱对其真伪进行快速识别.同时,本研究将大黄样品6次随机划分为训练集和测试集,建模预测平均识别率为93.4％,表明采用LSTSVM算法建立识别模型具有较好的稳健性.     

Differentiation of herbs linked to "Chinese herb nephropathy" from the liquid chromatographic determination of aristolochic acids

A HPLC method was developed and applied to analyze aristolochic acids (AA-I and AA-II) in Chinese medicinal herbs. The herb samples were extracted by using ultrasonication with the extraction efficiency of better than 82%. Extracts were then filtered and injected onto a C18 column eluting under a gradient program using methanol and water-containing 0.5% acetic acid. The method with the detection limits of 1.33 ng for AA-I and 7.29 ng for AA-II per injection was successfully applied for the analysis of traditional Chinese medicine (TCM) and related products and differentiation of Chinese medicinal herbs that have previously been misused and caused toxicological effects. The developed protocol provided an example that analysis of selected component markers could serve for health security and quality control of TCM consumption.     

Screening and identification of multi-component in Qingkailing injection using combination of liquid chromatography/time-of-flight mass spectrometry and liquid chromatography/ion trap mass spectrometry

An approach for screening and identification of multi-component in complex traditional Chinese medicine systems with a combinative LC/MS (MSⁿ) technique was described in this paper. The chemical profile of Qingkailing injection, a well-known traditional Chinese formula in China, was studied using the established method as for an application. Benefit from combining the accurate mass measurement of LC/TOF-MS to generate elemental compositions and the complementary multilevel structural information provided by LC/ion trap MSⁿ, 33 components in Qingkailing injection were identified in all. The three isomers of chlorogenic acid, isochlorogenic acid and neochlorogenic acid which are derived from Flos Lonicerae, one of the medicinal materials in Qingkailing, were differentiated by verifying their MS³ fragmentation data. All the components identified were surveyed and classified according to their medicinal materials derivation. This study is expected to provide an effective and reliable pattern for comprehensive and systematic characterization of the complex traditional Chinese medicine systems.     

植物类中药中微量元素的因子分析和聚类分析

尝试利用化学计量学方法探讨微量元素含量与中药药性的相关性。对１０５味植物类中药４２种微量元素测定数据用因子分析和聚类分析进行了多因素分析。因子分析证实了一个１０因子模型合理解释这些微量元素间的相关关系；样本聚类分析证明了１０５株中药合理地聚类成不同组；     

玫瑰红景天药用历史及功能简介

玫瑰红景天具有上千年的药用历史,是我国传统中药中的瑰宝。大量研究表明,玫瑰红景天提取物对人体中枢神经系统、心血管系统以及内分泌系统具有保护和调节作用,尤其在抗疲劳、抗抑郁、抗肿瘤及提高人体免疫力等方面具有独特的药效。本文介绍了玫瑰红景天的药用开发历史及其特征活性成分的功能,以期提高人们对这种传统中药的认识,为进一步开发玫瑰红景天的药用功能提供借鉴和参考。     

Determination of baicalin, chlorogenic acid and forsythin in Chinese medicinal preparation by capillary electrophoresis

Summary The determination of baicalin, chlorogenic acid and forsythin in a traditional Chinese medicinal preparation, Shuanghuanglian oral liquid, has been investigated by micellar electrokinetic capillary electrophoresis using borate buffer, SDS and acetonitrile as background electrolyte, 15 kV applied voltage and UV detection, the three active compounds were completely separated within 15 min. The effect of buffer pH, concentration of borate and SDS are discussed. Regression equations reveal linear relationships between the peak-area of each component and content. In addition, the levels of three active compounds in traditional Chinese medicinal preparation, Shuanghuanglian oral liquid, were easily determined with recoveries of 95.20–105.73%.     

Application to the Determination of Ecdysterone in Traditional Chinese Medicine Loulu by High Performance Liquid Chromatography Coupled with Flow Injection Micro-column Pre-separation Technique

Loulu is a traditional Chinese medicine which has obvious activities in anti-peroxidantion, anti-atherosclofosis and immunopotentintion. The pharmacological activities of ecdysterone in Loulu are in good agreement with the curative effects of Loulu. Therefore, the quantitative determination of ecdysterone in Loulu will be helpful in further researching the medicinal mechanism. The components of Loulu are very complex. Many overlapping peaks from interference will be present in chromatograms if the sample is directly determined by HPLC. So it is very important to search for a simple, rapid and effective sample pretreatment technique. Flow injection analysis, as an effective sample treatment technique, has applied in many fields. In this work, a flow injection micro-column system for the sample pretreatment coupling HPLC was proposed. Ecdysterone in.Loulu was pre-separated with the designed system, and then determined by HPLC. The separation performance, the influence factors of the pre-separation and the operation parameters of the HPLC have investigated in detail. The experimental results demonstrated that the present system is simple, efficient and no pollution. The method was applied to the determination of ecdysterone in real samples.     

Analysis and confirmation of synthetic anorexics in adulterated traditional Chinese medicines by high-performance capillary electrophoresis.

Six synthetic anorexics, clobenzorex, diethylpropion, fenfluramine, methamphetamine, phenylpropanolamine and phentermine, which can be found as adulterants in traditional Chinese medicines were assayed simultaneously by high-performance capillary electrophoresis. The electrolyte was a buffer solution containing 120 mM phosphate buffer (NaH2PO4/H3PO4, pH 2.0) and 15% acetonitrile. Applied voltage was 16 kV and temperature was 30 degrees C. Fluoren-2,7-diammonium chloride was used as an internal standard and detector set at 200 nm. The recoveries of the synthetic anorexic adulterants in traditional Chinese medicinal formula using C8-SCX mixed solid-phase extraction were studied. Several traditional Chinese medicinal powders obtained from clinics were also studied by the above HPCE method and confirmed by GC-MS. Clobenzorex, diethylpropion and fenfluramine were found and determine in these samples.     

High-performance liquid chromatographic method for the determination and pharmacokinetic study of mangiferin in plasma of rats having taken the traditional Chinese medicinal preparation Zi-Shen pill

A high-performance liquid chromatographic method for the determination and pharmacokinetic study of mangiferin in the plasma of rats that have been orally administered the traditional Chinese medicinal preparation Zi-Shen pill is established. Plasma samples taken from rats are pretreated by protein precipitation with acetonitrile. Separation of the main effective constituent mangiferin is accomplished on a C18 stationary phase and a mobile phase of methanol&-water (25:75, v/v) with 0.6% glacial acetic acid. The UV detection wavelength is set at 320 nm, and the detection limit for mangiferin in plasma is 0.163 micro g/mL. After validation, the method is used to take a limited view of pharmacokinetic profiles of the traditional Chinese medicinal preparation Zi-Shen pill.     

八种解表中草药中微量元素的测定

采用火焰原子吸收分光光度法测定了八种解表中草药中Fe、Cu、Mn、Ca等九种元素的含量。结果表明,该类中药含有较丰富的铁、铜,但Zn、Mg含量较低,为进一步探讨微量元素与药效的关系提供了有用的数据。