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Development and Validation of Liquid Chromatographic Method for the Determination of the Related Substances of Rifampicin 被引量:2
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作者 朱斌 胡昌勤 《Journal of Chinese Pharmaceutical Sciences》 CAS 2002年第1期19-23,共5页
A number of HPLC methods have been approved for the determination of rifampicin, but no references involved the assay of related substances of rifampicin. In the present paper, a reversed-phase liquid chromatographic ... A number of HPLC methods have been approved for the determination of rifampicin, but no references involved the assay of related substances of rifampicin. In the present paper, a reversed-phase liquid chromatographic method for the determination of related substances of rifampicin is developed and validated. Rifampicin and its related substances, including rifamycin SV, rifampicin N-oxide and 3-formylrifamycin SV were separated using a Zorbax Eclipse C8, 250×4.6 mm(i.d), 5 μm column by isocratic elution at a flow rate of 1 mL·min -1. The detector was set at 254 nm. The mobile phase is a mixture of methanol-acetonitrile -0.075 mol·L -1 monopotassium phosphate -1.0 mol·L -1 citric acid (31:31:35:3, v/v). The method validation included accuracy, precision, linearity, sensitivity and stability. All results are shown to be acceptable. 展开更多
关键词 RIFAMPICIN related substances HPLC
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Analysis of bacitracin and its related substances by liquid chromatography tandem mass spectrometry 被引量:3
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作者 Suleiman Ahmed Suleiman Fan Song +2 位作者 Mengxiang Su Taijun Hang Min Song 《Journal of Pharmaceutical Analysis》 SCIE CAS CSCD 2017年第1期48-55,共8页
A suitable liquid chromatography quadrupole time-of-flight mass spectrometric(LC–Q-TOF–MS) method was developed for separation and characterization of related substances in bacitracin test drug. The separation was p... A suitable liquid chromatography quadrupole time-of-flight mass spectrometric(LC–Q-TOF–MS) method was developed for separation and characterization of related substances in bacitracin test drug. The separation was performed on Li Chrospher RP-18 column using methanol as mobile phase A and 0.2% ammonium acetate buffer solution as mobile phase B in gradient elution. A total of 12 related substances were detected through high resolution mass spectrometric determination in a positive electrospray ionization mode. They were identified as co-existing active components and degradation products of bacitracin through the analysis and elucidation of both the protonated parents and the product ions of all the related substances and their fragmentation pathways were also proposed. 展开更多
关键词 BACITRACIN DEGRADATION products FRAGMENTATION PATHWAYS related substances LC–Q-TOF–MS
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Validated gradient stability indicating HPLC method for determining Diltiazem Hydrochloride and related substances in bulk drug and novel tablet formulation 被引量:2
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作者 Vivekanand A.Chatpalliwar Pawan K.Porwal Neeraj Upmanyu 《Journal of Pharmaceutical Analysis》 SCIE CAS 2012年第3期226-237,共12页
A stability-indicating liquid chromatographic method has been developed and validated for the determination of Diltiazem Hydrochloride(DTZ) together with its six related substances(Diltiazem sulphoxide,Imp-A,Imp-B,Imp... A stability-indicating liquid chromatographic method has been developed and validated for the determination of Diltiazem Hydrochloride(DTZ) together with its six related substances(Diltiazem sulphoxide,Imp-A,Imp-B,Imp-D,Imp-E,and Imp-F) in a laboratory mixture as well as in a novel tablet formulation developed in-house.Efficient chromatographic separation was achieved on a Hypersil BDS C18(150 mm*4.6 mm,5.0 μm) with mobile phase containing 0.2% Triethylamine(TEA) in gradient combination with acetonitrile(ACN) at a flow rate of 1.0 mL/min and the eluent was monitored at 240 nm.In the developed method,the resolution of DTZ from any pair of impurities was found to be greater than 2.0.The test solution and related substances were found to be stable in the diluent for 24 h.The developed method resolved the drug from its known impurities,stated above,and also from additional impurities generated when the formulation was subjected to forced degradation;the mass balance was found close to 99.9%.Regression analyses indicate correlation coefficient value greater than 0.997 for DTZ and its six known impurities.The LOD for DTZ and the known impurities was at a level below 0.02%.The method has shown good,consistent recoveries for DTZ(99.8-101.2%) and also for its six known impurities(97.2-101.3%).The method was found to be accurate,precise,linear,specific,sensitive,rugged,robust,and stability-indicating. 展开更多
关键词 Diltiazem Hydrochloride BENZODIAZEPINE STABILITY-INDICATING related substances ICH guidelines HPLC
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Analysis of ganciclovir and its related substances using high performance liquid chromatography and liquid chromatography-mass spectrometry methods 被引量:1
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作者 Cheng-Ping Li1,2,Mao Mao1,Lan-Jun Zheng1,Wei-Guang Shan11.College of Pharmaceutical Sciences,Zhejiang University of Technology,Hangzhou 310032 2.College of Biology and Environment Engineering,Zhejiang Shuren University,Hangzhou 310015,China 《Journal of Pharmaceutical Analysis》 SCIE CAS 2010年第4期218-222,共5页
Objective High performance liquid chromatography(HPLC)and liquid chromatography-mass spectrometry(LC/MS)methods were developed for the determination of ganciclovir and its related substances.Methods A Hypersil ODS2 co... Objective High performance liquid chromatography(HPLC)and liquid chromatography-mass spectrometry(LC/MS)methods were developed for the determination of ganciclovir and its related substances.Methods A Hypersil ODS2 column(4.6 mm×250 mm,5 μm)was used with a mobile phase of 0.02 M potassium dihydrogen phosphate buffer(pH 6.0)-methanol(92∶8)at a flow rate of 1.0 mL/min,and UV detector set at 254 nm was used for monitoring the eluents.Results The method was simple,rapid,selective and capable of separating all related substances at trace level with a detection limit of 0.04 μg/mL.It has been validated with respect to accuracy,precision,linearity,and limits of detection and quantification.The linearity range was 10.2-153.0 μg/mL with r=0.9998.The percentage recoveries ranged from 96.7% to 101.6%,and RSD was 1.24%-1.96%(n=5).Conclusion The method was found to be suitable not only for monitoring the reactions during the process development but also for quality control of ganciclovir.For identification of related substances,LC/MS was used.The mainly related substances of ganciclovir active pharmaceutical ingredients(API)were determined as guanine,(1,3-dioxolan-4-yl)methyl acetate,and diacetyl guanine. 展开更多
关键词 GANCICLOVIR related substances high performance liquid chromatography high performance liquid chromatography/mass spectrometry
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Identification and characterization of related substances in EVT-401 by hyphenated LC–MS techniques
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作者 Binan Zhu Yuting Lu +4 位作者 Leilin Chen Binbin Yu Yuexin Liu Min Song Taijun Hang 《Journal of Pharmaceutical Analysis》 SCIE CAS CSCD 2017年第4期223-230,共8页
A sensitive and selective method was developed for the separation and characterization of related substances(RSs) in EVT-401 by hyphenated LC–MS techniques. Complete separation of the RSs was achieved with an Inertsi... A sensitive and selective method was developed for the separation and characterization of related substances(RSs) in EVT-401 by hyphenated LC–MS techniques. Complete separation of the RSs was achieved with an Inertsil ODS-SP column(250 mm×4.6 mm, 5 μm) by linear gradient elution using a mobile phase consisting of 0.2% formic acid solution, methanol and acetonitrile. EVT-401 was found to be susceptible to acid, alkaline and oxidative stresses, while relatively stable under photolytic and thermal dry stress conditions. Fourteen RSs including six process-related substances and eight degradation products were detected and identified in EVT-401 with positive ESI high-resolution TOF-MS analysis of their parent ions and the corresponding product mass spectra elucidation, and some of them were further verified by chemical synthesis and NMR spectroscopy. The specific LC–MS method developed for separation, identification and characterization of RSs is valuable for EVT-401 manufacturing process optimization and quality control. 展开更多
关键词 EVT-401 related substances LC–MS DEGRADATION PRODUCTS
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Determination of 9-Deoxo-9a-Aza-9a-Homoerythromycin A and Related Substances by High-Performance Liquid Chromatography
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作者 史颖 姚国伟 +1 位作者 欧育湘 马敏 《Journal of Beijing Institute of Technology》 EI CAS 2005年第4期420-424,共5页
A high-performance liquid chromatography(HPLC) method was developed and validated for the assay of 9-deoxo-9a-aza-9a-homoerythromycin A and related substances that might coexist in products as impurities that origin... A high-performance liquid chromatography(HPLC) method was developed and validated for the assay of 9-deoxo-9a-aza-9a-homoerythromycin A and related substances that might coexist in products as impurities that originate from the synthesis processes. A chromatographic system comprising an ODS 150 mm× 4.6 mm I.D. column, a mobile phase of cetonitrile monobasic potassium phosphate buffer (25/75), a flow rate of 1.2 mL/min, a temperature of 30 ℃and a UV detector set at 205 nm has shown good chromatographic separation for 9-deoxo-9a-aza-9a-homoerythromycin A and other related substances. The linearity of the calibration curves, the precision, expressed as relative standard deviations, of the HPLC method have been studied. The HPLC method under study was found to be specific, precise, accurate and reproducible, indicating stability. 展开更多
关键词 9-deoxo-9a-aza-9a-homoerythromycin A related substances HPLC
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LC-MS/MS Method Applied to the Detection and Quantification of Ursodeoxycholic Acid Related Substances in Raw Material and Pharmaceutical Formulation
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作者 Boscolo Oriana Flor Sabrina +4 位作者 Dobrecky Cecilia Martinefski Manuela Tripodi Valeria Lucangioli Silvia Silvia Lucangioli 《Journal of Pharmacy and Pharmacology》 2018年第5期448-455,共8页
Objective: To develop a highly sensitive LC-MS/MS (liquid chromatography-mass spectxometry/mass spectrometry) method applied to the detection and quantitation of UDCA (ursodeoxycholic acid) related substances suc... Objective: To develop a highly sensitive LC-MS/MS (liquid chromatography-mass spectxometry/mass spectrometry) method applied to the detection and quantitation of UDCA (ursodeoxycholic acid) related substances such as CA (cholic acid), DCA (deoxycholic acid), CDCA (chenodeoxycholic acid) and LCA (lithocholic acid) in raw material and pharmaceutical formulation. Methods: The method was validated for specificity, linearity, accuracy, precision, robustness. A triple quadrupole mass detector was employed, equipped with an ESI (electrospray ionization) source operated in the negative ion mode. The chromatographic system consisted of a Symmetry C 18 column (150 mm × 4.6 mm, id; particle size 5 μm) and methanol-acetonitrile-ammonium acetate (pH 7.6; 10 mM) (40:40:20, v/v/v) as the mobile phase. The chromatographic conditions were 25 uL injection volume, flow rate of 0.4 mL/min and column temperature set at 35℃. Key tindings: The method requires a minimum sample amount and presents very low LOD (limits of detection) for CA (0.29 ng/mL), DCA (0.59 ng/mL), CDCA (0.13 ng/mL) and LCA (0.44 ng/mL) in comparison to LC methods coupled to different detectors like UV (ultraviolet), fluorescence and refractive index. Conclusions: The developed and validated LC-MS/MS method for the determination of UDCA and related substances in raw material and in a suspension was advantageous since it required a minimum sample amount. In turn, it could be used as a stability indicating method. 展开更多
关键词 UDCA related substances LC mass detector pharmaceutical formulation.
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PIVKA-Ⅱ、GGT、GPR、GLR、PLR对乙型肝炎相关性原发性肝癌的诊断价值研究
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作者 黄琴 彭晓明 +1 位作者 梅丽萍 韩竖霞 《中西医结合肝病杂志》 CAS 2024年第4期327-330,共4页
目的:探讨维生素K缺乏或拮抗剂-Ⅱ诱导蛋白(PIVKA-Ⅱ)、γ-谷氨酰转肽酶(GGT)、γ谷氨酰转肽酶与血小板计数比值(GPR)、γ-谷氨酰转肽酶与淋巴细胞计数比值(GLR)、血小板患者与淋巴细胞计数比值(PLR)在乙型肝炎病毒(HBV)感染后所致不同... 目的:探讨维生素K缺乏或拮抗剂-Ⅱ诱导蛋白(PIVKA-Ⅱ)、γ-谷氨酰转肽酶(GGT)、γ谷氨酰转肽酶与血小板计数比值(GPR)、γ-谷氨酰转肽酶与淋巴细胞计数比值(GLR)、血小板患者与淋巴细胞计数比值(PLR)在乙型肝炎病毒(HBV)感染后所致不同肝脏疾病患者中的变化情况以及单独和联合检测对乙型肝炎相关性原发性肝癌的诊断价值。方法:回顾性分析2020年1月至2022年12月收治的241例HBV相关性肝病患者的临床资料,其中慢性乙型肝炎(CHB)患者83例,乙型肝炎相关性肝硬化(HBV-LC)患者82例,乙型肝炎相关性原发性肝癌(HBV-HCC)患者76例,另选取同期健康体检人员81例为正常对照组(NC)。统计分析4组患者的PIVKA-Ⅱ、GGT、GPR、GLR、PLR表达差异以及血清PIVKA-Ⅱ、GGT的阳性率情况;Pearman线性相关分析HBV-HCC组患者的GLR、GPR、PLR指标与血清PIVKA-Ⅱ、GGT的相关性;采用ROC曲线分析PIVKA-Ⅱ、GGT、GLR、GPR、PLR单独与联合检测对HBV-HCC的诊断价值。结果:CHB组、HBV-LC组、HBV-HCC组患者的PIVKA-Ⅱ、GGT、GLR、GPR水平依次增加,其中两两组比较,GGT、GLR、GPR水平均差异有统计学意义(P<0.05),HBV-HCC组的PIVKA-Ⅱ表达水平高于CHB组、HBV-LC组(P<0.05)。CHB组、HBV-LC组的PIVKA-Ⅱ、PLR水平均低于NC组(P<0.05)。HBV-HCC组血清PIVKA-Ⅱ、GGT阳性率都大于50%。HBV-HCC组患者的GLR、GPR、PLR与血清PIVKA-Ⅱ、GGT均呈正相关。PIVKA-Ⅱ、GGT、GLR、GPR联合检测的诊断敏感度曲线下面积(AUC)以及约登(Youden)指数均高于PIVKA-Ⅱ、GGT、GLR、GPR、PLR单独检测,GGT、GLR、GPR三者联合检测的特异度达到95.06%。结论:PIVKA-Ⅱ、GGT、GPR、GLR、PLR在HBV感染所致不同肝脏疾病患者中具有一定的差异,PIVKA-Ⅱ、GGT、GPR、GLR联合检测有助于HBV-HCC的早期诊断。 展开更多
关键词 乙型肝炎相关性原发性肝癌 维生素K缺乏或拮抗剂-诱导蛋白 Γ-谷氨酰转肽酶 γ-谷氨酰转肽酶与血小板比值 γ-谷氨酰转肽酶与淋巴细胞计数比 血小板计数与淋巴细胞计数比值 诊断价值
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铝镁混悬液(Ⅱ)在酸相关性疾病中的应用
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作者 张德新 张延祯 +1 位作者 熊哲锟 魏明通 《智慧健康》 2024年第8期80-83,共4页
目的探究铝镁混悬液(Ⅱ)在酸相关性疾病中的应用现状分析。方法选取2022年4月—2023年4月本院收治的酸相关性疾病患者202例临床资料开展回顾性分析。分析患者基本人口学特征、生命体征、既往史、主要临床症状及诊断、疗效结果分析、治... 目的探究铝镁混悬液(Ⅱ)在酸相关性疾病中的应用现状分析。方法选取2022年4月—2023年4月本院收治的酸相关性疾病患者202例临床资料开展回顾性分析。分析患者基本人口学特征、生命体征、既往史、主要临床症状及诊断、疗效结果分析、治疗期间不良反应发生情况,为优化诊疗方案寻求循证医学支持。结果抗酸药记录表1填写者202例,其中铝镁混悬液(Ⅱ)为抗酸药物使用最常见药物。使用铝镁混悬液(Ⅱ)治疗的130例患者中男性76例,女性54例;年龄阶段以23~55岁居多;收缩压平均值106~120mmHg居多;舒张压平均值66~80mmHg居多;体重平均值51~70kg居多;心率平均值76~90次/分居多;既往疾病史中发生率最高的为高血压;个人史中发生率最高为饮酒史;既往治疗用药最常见为奥美拉唑。常出现的几种症状发生率依次为反酸、烧心、腹痛、嗳气、黑便;而临床诊断统计中显示主要为慢性胃炎。铝镁混悬液(Ⅱ)治疗130例患者的总体疗效有效率为95.89%。药物不良反应者1例,具体为大便黏稠和胃肠道不适。结论铝镁混悬液(Ⅱ)在酸相关性疾病中临床应用较为普遍,使用群体较为广泛,临床治疗疗效较好,且安全性较好。 展开更多
关键词 酸相关性疾病 症状 治疗 铝镁混悬液() 应用现状
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Cefotiam hydrochloride for injection of related substance in clavulante potassium by LCMS-IT-TOF
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作者 Yu-Biao Lin Hao-Fei Fan +4 位作者 Gui-Fang Yang Wen-Li Xiao Jun Wang Bo Yang Qi-Bing Liu 《Journal of Hainan Medical University》 2018年第19期5-9,共5页
Objective: To analyze the related substances in Cefotiam Hydrochloride for Injection. Methods: HPLC-IT-TOF, the HPLC condition: C18 (250 mm×4.6 mm, 5 μm);temp: 30℃;mobile phase: A) 0.02 mol/L ammonium acetic;B)... Objective: To analyze the related substances in Cefotiam Hydrochloride for Injection. Methods: HPLC-IT-TOF, the HPLC condition: C18 (250 mm×4.6 mm, 5 μm);temp: 30℃;mobile phase: A) 0.02 mol/L ammonium acetic;B) methanol;flow tate: 1.0 mL/min;postcoiumn split ratio: 1:1;detection: UV254;elute by linear gradient. MS parameter: ion source: ESI(+);100-1000 m/z;ionization voltage: 3.0 kV;dry gas (N2);temp: 200 ℃;emale cone voltage 30 V(1)Result: Eight related substances were separated in products, of which three were elucidated in the production, Others are degradation impurities. Conclusion: There were several related substances during production of Cefotiam.LCMS-IT-TOF provided an effective method to determine the related substances and ensure the quality and safety of the product. 展开更多
关键词 CEFOTIAM Chromatography-mass SPECTROMETRY related substances
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注射用利培酮微球(Ⅱ)治疗急性期精神分裂症患者的疗效及安全性研究 被引量:9
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作者 李茜 张云淑 +12 位作者 严保平 王健 马燕娟 王媛 秦英杰 那龙 任智勇 孙俊伟 邓怀丽 马宏筠 曲雪慧 周楠 司天梅 《中国全科医学》 北大核心 2023年第32期4007-4012,共6页
背景长效抗精神病药是目前精神分裂症全病程治疗中的重要选择之一。注射用利培酮微球(Ⅱ)在剂型上进行了改良,治疗期间无需补充口服药物,能够快速起效,但目前尚缺少其临床疗效的相关研究。目的评估注射用利培酮微球(Ⅱ)治疗急性期精神... 背景长效抗精神病药是目前精神分裂症全病程治疗中的重要选择之一。注射用利培酮微球(Ⅱ)在剂型上进行了改良,治疗期间无需补充口服药物,能够快速起效,但目前尚缺少其临床疗效的相关研究。目的评估注射用利培酮微球(Ⅱ)治疗急性期精神分裂症患者的疗效及安全性。方法本研究为单臂多中心前瞻性研究,纳入2021年8月—2022年4月北京大学第六医院、河北省精神卫生中心、乌鲁木齐市第四人民医院、太原市精神病医院、天津市安定医院5个研究中心,18~55岁急性期精神分裂症患者为研究对象,给予25.0 mg/2周、37.5 mg/2周或50.0mg/2周可变剂量注射用利培酮微球(Ⅱ)治疗,随访8周。分别在基线和2、4、6、8周末进行阳性与阴性症状量表(PANSS)、临床总体印象量表(CGI)及精神科药物不良反应量表(UKU)评定。于基线及8周末进行个人和社会功能量表(PSP)评定,并采集患者实验室检查指标。结果研究共纳入58例患者。治疗2、4、6、8周末患者PANSS总分、阳性症状量表分、阴性症状量表分、一般精神病理量表分、CGI-疾病严重程度(CGI-S)评分均较基线降低(P<0.001);2、4、6周及8周末患者PANSS总分减分有效率分别为37.9%(22/58)、70.7%(41/58)、89.7%(52/58)和89.7%(52/58)。治疗8周末PSP评分[(71.00±14.99)分]高于基线[(46.28±15.43)分](P<0.001)。患者的平均血药浓度在1、2、4、6、8周末分别达到(12.94±8.47)、(13.23±10.86)、(21.09±13.04)、(23.64±14.23)、(29.08±19.51)μg/L。常见不良反应包括震颤、肌张力障碍、便秘等,均为轻度到中度,无严重不良反应及因无不良反应脱落者。治疗8周末泌乳素水平较基线升高(P<0.05)。结论注射用利培酮微球(Ⅱ)可在不补充口服抗精神病药的情况下快速起效,可有效改善精神分裂症急性期的多维度症状,且耐受性良好。 展开更多
关键词 精神分裂症 抗精神病药 长效抗精神病药 注射用利培酮微球() 治疗结果 药物相关性副作用和不良反应
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A Validated Stability-Indicating UHPLC Method for Determination of Naproxen and Its Related Compounds in Bulk Drug Samples 被引量:1
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作者 K. Tirumala Rao L. Vaikunta Rao 《American Journal of Analytical Chemistry》 2013年第6期286-292,共7页
A simple, rapid, precise, accurate, rugged and robust stability-indicating ultra-fast high performance liquid chromatographic (UHPLC) method has been developed for the estimation of related compounds (imp-A, imp-B, im... A simple, rapid, precise, accurate, rugged and robust stability-indicating ultra-fast high performance liquid chromatographic (UHPLC) method has been developed for the estimation of related compounds (imp-A, imp-B, imp-C, imp-D and imp-E) in Naproxen and also the assay of Naproxen from bulk drug samples. The stability indicating capability of the method was proven by subjecting the samples to stress conditions such as acid, base, oxidation, photolysis and thermal degradation. The efficient chromatographic separation was achieved using mobile phase solution A prepared as buffer solution 10 mM monobasic potassium phosphate pH 4.0 ± 0.05 adjusted with diluted ortho phosphoric acid solution and solution B acetonitrile with linear gradient elution on poroshell 120 EC-C18 shot column (50 mm × 4.6 mm, 2.7 μm) and UV detection at 235 nm at a flow rate 1.0 mL/min, column oven temperature was set to 25?C. The above are all known impurities and degradation impurities are well resolved with Naproxen peak and these are eluted within a 10 min runtime of HPLC. The photo diode array detector was used for peak homogeneity testing during stress study experiments and the overall mass balance was found to be 99.2% to 100.2% in all stress conditions. The linear calibration range was found to be 0.05 μg/mL to 0.75 μg/mL for related compounds and 50 μg/mL to 150 μg/mL for Naproxen and the accuracy of the method was found to be 91.5% to 98.5% recovery for the related substance method and 95.4% to 97.4% recovery for the assay method. The Naproxen and related compounds were found to be stable up to 48 hours and the method validation data show excellent results for precision, linearity, specificity, limit of detection, limit of quantitation and robustness. The present method can be successfully used for routine QC and stability studies and it will help to reduce the analysis cost, time and effluent load compared to conventional HPLC methods. 展开更多
关键词 NAPROXEN STABILITY-INDICATING related substances ASSAY Validation UHPLC
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RUNX1在AngⅡ诱导心肌肥厚中的作用及机制 被引量:1
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作者 丁立群 王玉玖 +4 位作者 杨丽娟 沈嘉祺 王傲 邹明锐 刘宝辉 《滨州医学院学报》 2023年第6期401-405,共5页
目的探讨Runt相关转录因子1(RUNX1)对血管紧张素Ⅱ(AngⅡ)诱导的心肌肥厚的作用及机制。方法将H9C2心肌细胞分为Control组、L-AngⅡ组、M-AngⅡ组、H-AngⅡ组,验证AngⅡ诱导心肌肥厚模型并检测不同AngⅡ浓度下RUNX1表达情况。将H9C2心... 目的探讨Runt相关转录因子1(RUNX1)对血管紧张素Ⅱ(AngⅡ)诱导的心肌肥厚的作用及机制。方法将H9C2心肌细胞分为Control组、L-AngⅡ组、M-AngⅡ组、H-AngⅡ组,验证AngⅡ诱导心肌肥厚模型并检测不同AngⅡ浓度下RUNX1表达情况。将H9C2心肌细胞分为慢病毒转染无义序列(NS)组、AngⅡ+NS组、shRUNX1组、AngⅡ+shRUNX1组检测RUNX1对心肌肥厚的影响。采用Western blot法检测各组细胞RUNX1、SERCA2a表达量的变化,采用qRT-PCR法检测各组细胞心肌肥厚相关指标,采用免疫荧光法检测心肌细胞面积。结果在H9C2中加入AngⅡ48 h后,与对照组相比,AngⅡ处理后细胞中RUNX1蛋白表达量明显上调,并呈剂量依赖关系。转染shRUNX172 h后进行AngⅡ处理,与AngⅡ+NS组相比,AngⅡ+shRUNX1组BNP mRNA、RUNX1蛋白表达量明显降低,心肌细胞面积显著减小;而SERCA2a蛋白表达量明显上调。结论RUNX1参与AngⅡ诱导的心肌肥厚的病理过程,其作用机制可能与抑制SERCA2a相关。 展开更多
关键词 心肌肥厚 血管紧张素 Runt相关转录因子1 SERCA2A
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低强度超声波提升厌氧污泥对重金属Cu(Ⅱ)极限浓度调控效果
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作者 朱彦辉 朱易春 +2 位作者 刘祖文 田帅 李鑫 《有色金属科学与工程》 CAS 北大核心 2023年第3期400-406,共7页
以污泥基质降解速率(vCOD)、胞外聚合物(EPS)和酶活性(DHA)等变化为评价指标,探究了不同进水Cu(Ⅱ)浓度下低强度超声波提高厌氧污泥对重金属Cu(Ⅱ)耐受性影响的效应。结果表明,低强度超声波能够提高污泥微生物对Cu(Ⅱ)的耐受性。随着进... 以污泥基质降解速率(vCOD)、胞外聚合物(EPS)和酶活性(DHA)等变化为评价指标,探究了不同进水Cu(Ⅱ)浓度下低强度超声波提高厌氧污泥对重金属Cu(Ⅱ)耐受性影响的效应。结果表明,低强度超声波能够提高污泥微生物对Cu(Ⅱ)的耐受性。随着进水Cu(Ⅱ)浓度升高,超声组与对照组vCOD均下降,但超声组vCOD下降幅度更缓。超声组和对照组进水Cu(Ⅱ)浓度与污泥基质降解速率抑制百分比之间的关系拟合得到IC_(50)分别为94.62 mg/L和88.85 mg/L,表明低强度超声波能够提高厌氧污泥对Cu(Ⅱ)的抑制阈值。进水Cu(Ⅱ)浓度为1 mg/L时,超声组与对照组EPS含量略有提高,而后随着Cu(Ⅱ)浓度升高而逐渐降低,但超声组比对照组EPS含量更高,可能是低强度超声波通过促进污泥分泌更多的EPS降低了Cu(Ⅱ)的生物毒性。此外,超声组的DHA活性比对照组提高了3.95%~36.31%。因此,通过低强度超声波可以提高厌氧污泥对重金属Cu(Ⅱ)的耐受性,从而维持污水厌氧生物处理的稳定运行。 展开更多
关键词 低强度超声波 厌氧污泥 重金属Cu() 脱氢酶活性 胞外聚合物
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格列齐特片(Ⅱ)溶出曲线考察与有关物质测定
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作者 刘延娟 杨国宁 +2 位作者 蔡伟 赵蕊蕊 李鹏战 《中国药业》 CAS 2023年第20期113-116,共4页
目的评价山东省内流通的格列齐特片(Ⅱ)的质量。方法抽取国内8家企业生产并在山东省内流通的格列齐特片(Ⅱ)样品58批,按药物溶出曲线测定和相似性比较技术指导原则方法进行溶出曲线考察,并采用相似因子(f2)法比较。按2020年版《中国药典... 目的评价山东省内流通的格列齐特片(Ⅱ)的质量。方法抽取国内8家企业生产并在山东省内流通的格列齐特片(Ⅱ)样品58批,按药物溶出曲线测定和相似性比较技术指导原则方法进行溶出曲线考察,并采用相似因子(f2)法比较。按2020年版《中国药典(二部)》格列齐特片(Ⅱ)有关物质测定方法测定制剂中杂质B含量,并建立杂质谱。结果各企业样品溶出曲线与参比制剂比较,f2范围在58.7~80.2之间,相似性良好。各企业样品均有杂质B检出,杂质B含量在0.00006%~0.00176%之间,其中G企业样品检出批数及含量高于其他企业;建立的杂质谱主要存在6种杂质,指认出其中4种分别为对甲苯磺酰脲、对甲苯磺酰胺、杂质B、杂质Ⅰ。结论不同企业间样品质量存在一定差异,主要表现在溶出度和杂质含量方面。山东省内流通的格列齐特片(Ⅱ)药品整体质量良好,为了进一步提高产品的安全性和有效性,建议对其有关物质进行控制。 展开更多
关键词 格列齐特片() 溶出曲线 有关物质 杂质分析
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冠心病患者不同支架置入术后对支架内内膜增生及外周血Beclin-1,LC3-Ⅱ水平的影响 被引量:1
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作者 马军武 司丽萍 《中国循证心血管医学杂志》 2023年第6期730-733,共4页
目的探讨冠状动脉粥样硬化性心脏病(冠心病,CHD)患者不同支架置入术后对支架内内膜增生及外周血血清自噬相关蛋白(Beclin-1)、微管相关蛋白1轻链3-Ⅱ(LC3-Ⅱ)水平的影响。方法选取2018年1月至2021年1月于新乡市第二人民医院介入放射科... 目的探讨冠状动脉粥样硬化性心脏病(冠心病,CHD)患者不同支架置入术后对支架内内膜增生及外周血血清自噬相关蛋白(Beclin-1)、微管相关蛋白1轻链3-Ⅱ(LC3-Ⅱ)水平的影响。方法选取2018年1月至2021年1月于新乡市第二人民医院介入放射科收治的符合纳入标准的114例CHD患者作为研究对象,按照植入支架类型不同分为聚合物可降解药物涂层支架(BP-DES)组(n=51)和永久性聚合物药物涂层支架(PP-DES)组(n=63)。记录两组患者手术过程中靶血管病变相关情况及置入支架长度等,术后12个月采用血管内超声技术比较两组内膜增生情况,采用酶联免疫吸附法(ELISA)检测外周血血清中Beclin-1,LC3-Ⅱ水平,术后随访1年,记录期间两组发生的主要不良心血管事件(MACE)以及支架内血栓等终点事件发生情况。结果BP-DES组靶血管病变总数大于PP-DES组,置入支架长度、病变长度小于PP-DES组(P<0.05);经超声造影检测,BP-DES组内膜中度增生率为56.86%,高于PP-DES组的38.10%,BP-DES组内膜重度增生率为19.61%,低于PP-DES组的39.68%(P<0.05);BP-DES组外周血Beclin-1,LC3-Ⅱ水平均低于PP-DES组(P<0.05);BP-DES组支架内血栓发生率为1.96%,低于PP-DES组的12.70%(P<0.05)。两组靶血管病变位置、程度、长度、内膜轻度增生率以及总MACE发生率比较,差异无统计学意义(P>0.05)。结论与PP-DES相比,冠心病患者置入BP-DES可有效改善支架内内膜增生情况,抑制其过度增生,降低Beclin-1,LC3-Ⅱ水平以抑制心肌细胞自噬,同时还可减少支架内血栓的发生。 展开更多
关键词 冠心病 聚合物可降解药物涂层支架 永久性聚合物药物涂层支架 自噬相关蛋白 微管相关蛋白1轻链3-
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网络药理学探讨雾水葛防治Ⅱ型糖尿病的物质基础及作用机制
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作者 李汉成 曾茗 +1 位作者 莫紫娇 马德运 《肇庆学院学报》 2023年第5期47-53,共7页
通过网络药理学探讨雾水葛防治Ⅱ型糖尿病的物质基础及作用机制.首先通过文献调研获取雾水葛的活性成分,Pubchem等数据库分析雾水葛主要成分核心靶点,运用GeneCards获取Ⅱ型糖尿病靶点,通过微生信软件筛选雾水葛-Ⅱ型糖尿病的靶点交集,... 通过网络药理学探讨雾水葛防治Ⅱ型糖尿病的物质基础及作用机制.首先通过文献调研获取雾水葛的活性成分,Pubchem等数据库分析雾水葛主要成分核心靶点,运用GeneCards获取Ⅱ型糖尿病靶点,通过微生信软件筛选雾水葛-Ⅱ型糖尿病的靶点交集,进一步构建“活性成分-靶点-疾病”网络和蛋白质相互作用(PPI)网络,并进行KEGG和GO分析.研究发现雾水葛中含有丰富的熊果酸、东莨菪素、槲皮素及芹菜素等,这些活性成分通过调控INSR、ERBB2、AKT1及TEK等重要靶点,进一步影响PI3K/Akt通路、HIF-1通路及5-羟色胺能突触等信号通路发挥防治Ⅱ型糖尿病的作用. 展开更多
关键词 网络药理学 雾水葛 型糖尿病 物质基础 作用机制
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注射用亚胺培南西司他丁钠质量分析
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作者 彭洁 贾艳花 +5 位作者 李佩 肖慧 罗嘉琳 李何杏 王婷婷 洪建文 《中国抗生素杂志》 CAS CSCD 北大核心 2024年第3期297-303,共7页
目的 对国内市场中不同企业的注射用亚胺培南西司他丁钠的质量状况进行评价,发现质量风险点,为仿制药一致性评价提供质量控制关键点。方法 采用法定检验结合探索性研究的方法对样品进行检验,统计分析注射用亚胺培南西司他丁钠的整体质... 目的 对国内市场中不同企业的注射用亚胺培南西司他丁钠的质量状况进行评价,发现质量风险点,为仿制药一致性评价提供质量控制关键点。方法 采用法定检验结合探索性研究的方法对样品进行检验,统计分析注射用亚胺培南西司他丁钠的整体质量水平,分析不同企业产品的差异。结果 按法定标准检验,80批次抽验样品结果均符合规定。但发现原研产品的复溶时间更快;不同企业的产品有关物质和含量结果差异较大;现行质量标准差异较大亟待提高统一。探索性研究表明,样品复溶时间与制剂中亚胺培南晶癖及粒度相关;采用LC/MS等方法对本品有关物质的来源进行了归属,对部分杂质结构进行了推断;对本品的含量测定方法进行了优化。结论 国内市场中注射用亚胺培南西司他丁钠的质量总体较好;在开展仿制药一致性评价工作中,需关注亚胺培南的晶癖以及制剂的有关物质、含量、充氮工艺和异亚丙基丙酮等质量关键点;现行标准有待统一和提高。 展开更多
关键词 注射用亚胺培南西司他丁钠 质量分析 晶癖 有关物质 含量
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氨糖美辛肠溶片中盐酸氨基葡萄糖有关物质研究
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作者 薛巧如 刘冰滢 +2 位作者 邹瑜 黎淑贤 陈华 《中国药业》 CAS 2024年第18期57-62,共6页
目的 建立测定氨糖美辛肠溶片中盐酸氨基葡萄糖有关物质的高效液相色谱法,并分析其影响因素。方法 色谱柱为纳谱ChromCore AQ C18柱(250 mm×4.6 mm,3μm),流动相为水-乙腈(梯度洗脱),流速为1.0 mL/min,检测波长为280 nm,柱温为30℃... 目的 建立测定氨糖美辛肠溶片中盐酸氨基葡萄糖有关物质的高效液相色谱法,并分析其影响因素。方法 色谱柱为纳谱ChromCore AQ C18柱(250 mm×4.6 mm,3μm),流动相为水-乙腈(梯度洗脱),流速为1.0 mL/min,检测波长为280 nm,柱温为30℃,进样量为20μL。采用加速稳定性试验和辅料相容性试验,结合生产工艺分析有关物质的影响因素。结果 已知杂质果糖嗪、2,5-脱氧果糖嗪、吡嗪、5-羟甲基糠醛、糠醛、2-甲基吡嗪、吡咯-2-甲醛、5-甲基糠醛质量浓度分别在0.20~3.30μg/mL、0.20~3.00μg/mL、0.25~7.54μg/mL、0.18~7.04μg/mL、0.25~10.10μg/mL、0.25~10.18μg/mL、0.25~10.17μg/mL、0.26~10.50μg/mL范围内与峰面积线性关系良好(R2≥0.999);检测限为0.3~5.0μg/mL,定量限为0.7~20.1μg/mL;精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率为98.24%~101.20%,RSD为0.33%~2.19%(n=9)。影响制剂有关物质产生的因素为工艺、温度和时间,影响有关物质含量增长速率的因素除工艺外,还有辅料(主要为羟甲基淀粉钠)和水分。结论 该方法简便、准确、专属性好,可用于氨糖美辛肠溶制剂中盐酸氨基葡萄糖有关物质的检测。建议优化工艺中干燥温度及时间,考察添加辅料的合理性,并控制片剂中的水分,进一步提高制剂质量的均一性和稳定性。 展开更多
关键词 氨糖美辛肠溶片 盐酸氨基葡萄糖 高效液相色谱法 有关物质
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对甘精胰岛素有关物质分析用系统适用性试验的研究
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作者 丁晓丽 胡馨月 +4 位作者 孙悦 李晶 张慧 王岩 梁成罡 《中国药事》 CAS 2024年第2期175-183,共9页
目的:对不同企业甘精胰岛素有关物质分析用系统适用性试验进行研究,发现存在的问题,提示企业完善质量标准,更科学有效地控制产品质量。方法:采用高效液相色谱法及液质联用方法对不同企业有关物质分析用系统适用性试验进行研究评价,发现... 目的:对不同企业甘精胰岛素有关物质分析用系统适用性试验进行研究,发现存在的问题,提示企业完善质量标准,更科学有效地控制产品质量。方法:采用高效液相色谱法及液质联用方法对不同企业有关物质分析用系统适用性试验进行研究评价,发现存在多种问题。结果:部分企业系统适用性溶液中所用的“0A-甘精胰岛素”的结构经LC-MS/MS确认后,发现与理论序列不同,部分企业采用酶切方法制备系统适用性溶液,存在杂质较多、操作步骤复杂、溶液易浑浊等问题。结论:建议企业提高对系统适用性试验的重视程度,加强研究,完善质量标准,科学有效地进行药品质量控制。 展开更多
关键词 甘精胰岛素 有关物质 系统适用性试验 高效液相色谱法 液质联用技术 0A-甘精胰岛素 结构确认
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