In an emerging trend, more and more Internet users search for information from Community Question and Answer （CQA） websites, as interactive communication in such websites provides users with a rare feeling of trust....In an emerging trend, more and more Internet users search for information from Community Question and Answer （CQA） websites, as interactive communication in such websites provides users with a rare feeling of trust. More often than not, end users look for instant help when they browse the CQA websites for the best answers. Hence, it is imperative that they should be warned of any potential commercial campaigns hidden behind the answers. Existing research focuses more on the quality of answers and does not meet the above need. Textual similarities between questions and answers are widely used in previous research. However, this feature will no longer be effective when facing commercial paid posters. More context information, such as writing templates and a user’s reputation track, needs to be combined together to form a new model to detect the potential campaign answers. In this paper, we develop a system that automatically analyzes the hidden patterns of commercial spam and raises alarms instantaneously to end users whenever a potential commercial campaign is detected. Our detection method integrates semantic analysis and posters’ track records and utilizes the special features of CQA websites largely different from those in other types of forums such as microblogs or news reports. Our system is adaptive and accommodates new evidence uncovered by the detection algorithms over time. Validated with real-world trace data from a popular Chinese CQA website over a period of three months, our system shows great potential towards adaptive detection of CQA spams.展开更多
目的:总结分析质量源于设计(Quality by Design,QbD)理念在口腔膜剂的处方设计与评价中的应用,以期为研究者提供参考。方法:结合QbD的主要元素、实施步骤及辅助工具和基于QbD的口腔膜剂研发实例,对口腔膜剂的目标产品质量概况、关键物...目的:总结分析质量源于设计(Quality by Design,QbD)理念在口腔膜剂的处方设计与评价中的应用,以期为研究者提供参考。方法:结合QbD的主要元素、实施步骤及辅助工具和基于QbD的口腔膜剂研发实例,对口腔膜剂的目标产品质量概况、关键物料属性、关键工艺参数及关键质量参数等信息进行梳理。结果与结论:QbD是一种具有明确目标的,基于质量风险管理及科学可靠的产品和工艺开发的理念,包括确定目标产品质量概况和关键质量属性、风险评估、实验设计、设计空间控制策略和过程分析。口腔膜剂具有溶化快速、使用方便、剂量准确、便于携带等特点,服用时无需用水送服,适用于有特殊需求的人群,如用于治疗精神病、精神分裂症、躁狂症以及吞咽困难患者。QbD理念在常规剂型研发中应用较多,在口腔膜剂研发中应用的相关研究较少。与传统方法相比,QbD更多应用风险管理的科学知识,识别影响关键质量属性的关键物料属性和关键工艺参数的操作空间,并持续进行全生命周期管理,更有利于生产和监管部门了解产品的生产工艺及相关变更信息。展开更多
充分借鉴质量源于设计(QbD)的理念和方法,采用鱼骨分析法对影响替米沙坦氨氯地平双层片关键质量属性(CQA)的处方、过程、设备、环境、人员五大类过程因素进行剖析。运用失败模式和影响分析法(failure mode and effect analysis,FMEA)对...充分借鉴质量源于设计(QbD)的理念和方法,采用鱼骨分析法对影响替米沙坦氨氯地平双层片关键质量属性(CQA)的处方、过程、设备、环境、人员五大类过程因素进行剖析。运用失败模式和影响分析法(failure mode and effect analysis,FMEA)对各因素进行风险评估,并采用Plackett-Burman设计(PBD)对关键工艺参数(CPP)进行筛选。为确定设计空间的控制策略,采用Box-Behnken设计(BBD)对CPP进行优化,建立统计模型,用于分析替米沙坦氨氯地平双层片的制备过程。结果表明,物料温度为37℃、山梨醇粒径为90目、包衣粉用量为11.41%,此条件下自制双层片与原研制剂(Twynsta~?)中替米沙坦溶出曲线的相似因子(f_2)为94.2、有关物质(总杂)为0.90%,期望值能达到1.000。本试验证实通过设置95%置信区间,使设计空间边界的不确定性得到了较好的印证。结果表明,由此设计空间范围内制备的替米沙坦氨氯地平双层片符合拟定标准,且工艺稳定、可行。展开更多
文摘In an emerging trend, more and more Internet users search for information from Community Question and Answer （CQA） websites, as interactive communication in such websites provides users with a rare feeling of trust. More often than not, end users look for instant help when they browse the CQA websites for the best answers. Hence, it is imperative that they should be warned of any potential commercial campaigns hidden behind the answers. Existing research focuses more on the quality of answers and does not meet the above need. Textual similarities between questions and answers are widely used in previous research. However, this feature will no longer be effective when facing commercial paid posters. More context information, such as writing templates and a user’s reputation track, needs to be combined together to form a new model to detect the potential campaign answers. In this paper, we develop a system that automatically analyzes the hidden patterns of commercial spam and raises alarms instantaneously to end users whenever a potential commercial campaign is detected. Our detection method integrates semantic analysis and posters’ track records and utilizes the special features of CQA websites largely different from those in other types of forums such as microblogs or news reports. Our system is adaptive and accommodates new evidence uncovered by the detection algorithms over time. Validated with real-world trace data from a popular Chinese CQA website over a period of three months, our system shows great potential towards adaptive detection of CQA spams.
文摘目的:总结分析质量源于设计(Quality by Design,QbD)理念在口腔膜剂的处方设计与评价中的应用,以期为研究者提供参考。方法:结合QbD的主要元素、实施步骤及辅助工具和基于QbD的口腔膜剂研发实例,对口腔膜剂的目标产品质量概况、关键物料属性、关键工艺参数及关键质量参数等信息进行梳理。结果与结论:QbD是一种具有明确目标的,基于质量风险管理及科学可靠的产品和工艺开发的理念,包括确定目标产品质量概况和关键质量属性、风险评估、实验设计、设计空间控制策略和过程分析。口腔膜剂具有溶化快速、使用方便、剂量准确、便于携带等特点,服用时无需用水送服,适用于有特殊需求的人群,如用于治疗精神病、精神分裂症、躁狂症以及吞咽困难患者。QbD理念在常规剂型研发中应用较多,在口腔膜剂研发中应用的相关研究较少。与传统方法相比,QbD更多应用风险管理的科学知识,识别影响关键质量属性的关键物料属性和关键工艺参数的操作空间,并持续进行全生命周期管理,更有利于生产和监管部门了解产品的生产工艺及相关变更信息。
文摘目的研究金荞麦(Fagopyri Dibotryis Rhizoma,FDR)从饮片到标准汤剂的关键质量属性传递规律。方法收集15批FDR饮片,制备标准汤剂,测定出膏率,建立饮片和标准汤剂的高效液相色谱(HPLC)指纹图谱,采用超快速液相色谱-四级杆飞行时间质谱(ultra fast liquid chromatography quadrupole time-of-flight mass spectrometry,UFLC-Q-TOF-MS/MS)技术对标定的共有峰进行成分鉴定,HPLC法测定其中10个指标性成分的含量,以出膏率、指纹图谱共有峰传递数、指标性成分转移率为关键质量属性,分析从饮片到标准汤剂的传递规律。结果FDR饮片指纹图谱标定共有峰56个,其中38个传递到了标准汤剂,共有峰个数传递率67.86%,56个共有峰共鉴定了93个成分,包括鞣质类成分33个,酚类成分22个,黄酮类成分、苯丙素苷类成分各14个,氨基酸类成分4个,有机酸类成分3个,萜类成分、生物碱类成分及其他类成分各1个,其中6个鞣质类成分(原花青素A2、原花青素B1、原花青素B2、原花青素B3、原花青素C1和原花青素C2)、3个酚类成分(原儿茶酸、没食子酸和原儿茶醛)、4个黄酮类成分(儿茶素、表儿茶素、表儿茶素没食子酸酯和芦丁)采用对照品比对确认,原儿茶酸、没食子酸、原儿茶醛、原花青素A2、原花青素B1、原花青素B3、原花青素C1、儿茶素、表儿茶素、表儿茶素没食子酸酯平均转移率分别为115.50%、81.36%、126.36%、36.86%、69.60%、47.15%、43.10%、86.78%、69.00%、16.18%,标准汤剂的出膏率范围为6.36%~10.61%。结论本研究为FDR配方颗粒制备工艺和质量标准研究奠定了基础。
文摘充分借鉴质量源于设计(QbD)的理念和方法,采用鱼骨分析法对影响替米沙坦氨氯地平双层片关键质量属性(CQA)的处方、过程、设备、环境、人员五大类过程因素进行剖析。运用失败模式和影响分析法(failure mode and effect analysis,FMEA)对各因素进行风险评估,并采用Plackett-Burman设计(PBD)对关键工艺参数(CPP)进行筛选。为确定设计空间的控制策略,采用Box-Behnken设计(BBD)对CPP进行优化,建立统计模型,用于分析替米沙坦氨氯地平双层片的制备过程。结果表明,物料温度为37℃、山梨醇粒径为90目、包衣粉用量为11.41%,此条件下自制双层片与原研制剂(Twynsta~?)中替米沙坦溶出曲线的相似因子(f_2)为94.2、有关物质(总杂)为0.90%,期望值能达到1.000。本试验证实通过设置95%置信区间,使设计空间边界的不确定性得到了较好的印证。结果表明,由此设计空间范围内制备的替米沙坦氨氯地平双层片符合拟定标准,且工艺稳定、可行。
