阿奇霉素有关物质测定方法的优化分析

目的采用色谱分析法对阿奇霉素相关物质的进行测定,探讨测定方法的优化。方法采用相色谱系统仪器、岛津Class-10Avp系统完成测定,色谱柱为SHISEIDO CAPCELL PAK C18 MG,规格为5μm,250mm×4.6mm。流动相为磷盐酸缓冲液,以0.05mol/L的磷酸氢二钾溶液,以浓度为20%的磷酸调节,直至pH值为8.2;色谱纯试剂乙腈为45∶55;色谱柱温度为30℃;流速为每分钟10mL;检测波长为210nm;进样量为50μL。结果溶液浓度为10~1000μg/mL的范围内的线性关系,结果表明线性关系良好。方法的最低检出限为100ng,r=0.9999。结论本次研究所采用的测定方法能够有效测定阿奇霉素中的相关物质,具有良好的分离性与浓度峰面线性关系。     

Sample Size Estimation Based on Event Data for a Two-Stage Survival Adaptive Trial with Different Durations

In clinical development, an adaptive design combining results from two separate studies (e.g., a seamless adaptive design with a dose finding study phase and a confirmatory study phase) is commonly considered. The purpose of an adaptive design is not only to reduce lead time between the two studies, but also to evaluate the treatment effect in a more efficient way. In this paper, the focus is on the case where the study objectives are the same but the time durations of the study periods are different in the two stages. In particular, event data are collected in both stages. Statistical procedure for combining data observed from the two different stages is discussed. Furthermore, results on hypotheses testing and sample size calculation are derived for the comparison of two treatments.     

卡培他滨中有机残留溶剂的检测

目的建立气相色谱法测定卡培他滨原料药中二氯甲烷、乙醇、甲醇和乙酸乙酯4种有机溶剂。方法采用DB-624毛细管柱,FID检测器,以DMSO为溶剂。结果各有机溶剂的平均加样回收率为93.7%～97.6%,RSD为2.5%～3.7%。结论该方法稳定准确,可用于卡培他滨中有机溶剂残留的检测。     

实时细胞电子分析技术用于水蛭、三七质量评价的初步研究

采用实时细胞电子分析技术测定水蛭、三七不同样本的时间剂量依赖性细胞反应曲线(TCRPs),对不同产地样本的TCRPs进行分析,并对生物活性强弱进行排序.同时,采用中国药典2010年版中的化学检测法和凝血酶滴定法分别对水蛭、三七各样本进行同步分析,比较不同检测方法得出结果的相关性.可见以实时细胞电子分析技术为基础的细胞生物活性测定结果与另两法所得结果基本一致.说明本技术能反映中药生物活性,有望为中药质量标准研究提供一种新方法.     

Simultaneous Determination of Six Quaternary Ammonium Alkaloids in Coptidis Rhizoma by UPLC

Objective To establish a new, rapid, and reliable reversed-phase ultra performance liquid chromatography (RP-UPLC) method for the simultaneous determination of six quaternary ammonium alkaloids (QAAs) in Coptidis Rhizoma. Methods The effect of different experimental parameters on the analysis of QAAs by RP-UPLC was evaluated. Results Optimal resolution was achieved with an Acquity UPLC BEH C18 column using a gradient elution profile and a mobile phase consisting of water spiked with 10 mmol/L ammonium bicarbonate (A, pH adjusted to 10.0 by ammonia water) and acetonitrile (B), at a flow rate of 0.30 mL/min and wavelength of 345 nm. The column temperature was set at 30 ℃. The proposed method was found to be reproducible, precise, and rapid according to the method validation. Conclusion The proposed method, which is compatible with MS analysis and the preparation of QAA, provides some helpful insights into the quality control of Coptidis Rhizoma.     

乳汁中药物浓度测定的研究进展

母乳喂养对婴儿来说是一种非常健康及有营养的获取能量的方式，对母亲和婴儿都有益处。患有某些疾病的哺乳母亲在进行药物治疗时，需要考虑药物是否会进入乳汁而对婴儿产生一些不良反应或对母亲产生影响。由于许多药物的哺乳期用药安全性并不十分明确，因此在临床治疗中不推荐哺乳期妇女使用。测定乳汁中的药物浓度可以明确合理的给药时间和给药剂量，提高用药安全性，对临床用药具有非常重要的意义。但乳汁成分复杂，含有大量脂质和蛋白质等干扰物质，使乳药浓度测定有一定困难。本文综述了国内外乳药浓度测定方法，以期为哺乳期合理用药提供参考。     

基于AHP-熵权法优选黑顺片炮制工艺及生物碱类成分动态变化研究

目的 采用主观评价层次分析法（analytic hierarchy process，AHP）-熵权法优选黑顺片炮制工艺，探究炮制过程中生物碱类成分动态变化规律。方法 采用外观性状、水溶性浸出物、苯甲酰新乌头原碱含量、苯甲酰乌头原碱含量、苯甲酰次乌头原碱含量、双酯型生物碱总量作为评价指标，基于单因素考察结果，以煮制时间、水漂次数、蒸制时间、干燥温度为主要因素建立正交实验，通过AHP-熵权法优选黑顺片最佳炮制工艺参数。采用HPLC法对各炮制环节的附子进行含量测定，分析比较6种酯型生物碱的含量变化。结果 在质量分数20%以上的胆巴溶液中浸泡能达到防腐的目的，且浸泡20d以上附子的质量相对稳定。黑顺片炮制的最佳工艺条件为煮制时间8min，水漂次数4次，蒸制时间3h，干燥温度60℃；炮制过程中双酯型生物碱总量逐渐降低，泡胆和漂洗过程单酯型生物碱含量降低，煮制和蒸制过程单酯型生物碱含量升高。结论 实验优化所得的黑顺片炮制工艺合理、稳定、可行，炮制过程中各环节对酯型生物碱类成分均有不同程度的影响，可为进一步探讨黑顺片的现代炮制方法提供参考。     

健康指导对血比重异常献血人群的影响

目的：探讨健康指导对血比重异常献血人群的影响。方法：指定专人负责资料收集,对102名低血比重献血者进行3～6个月健康指导,测定干预后血比重。结果：干预3个月后63名献血者测定合格,3～6个月间18名献血者测定合格,共有21名献血者检测为不合格。81名合格献血者中72名参加了献血。结论：通过健康指导提高了低血比重人群对不良生活方式的认知并且对扩大无偿献血人群有积极效果。     

Morphometric evaluation of the foramen magnum for sex determination: A study from Saudi Arabia

The present study provides a database of various morphometric dimensions of the foramen magnum region in the Saudi population. The objective of this study was to evaluate various measurements of the foramen magnum region for sex determination in the Saudi population by using computed tomography (CT) images. The various radiological measurements of the foramen magnum region were measured in a total of 200 adult subjects of Saudi origin including 100 males and 100 females. Sexual dimorphism was observed in five parameters related to the foramen magnum, namely length of the right occipital condyle (LROC), length of the left occipital condyle (LLOC), width of the foramen magnum (WFM), area of the foramen magnum (AFM) and length of the foramen magnum (LFM). The accuracy to discriminate sex ranged from 65.5% to 62.5% when LROC, LLOC, WFM, AFM, and LFM were considered as individual parameters. When multiple parameters were combined to discriminate sex, the highest accuracy of 71% was achieved.