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基于多变量数据分析的生物药制剂处方稳健性研究
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作者 聂磊 方伟杰 +4 位作者 郭婷婷 钱慈 章熠 瞿海斌 王海彬 《中国新药杂志》 CAS CSCD 北大核心 2023年第6期576-582,共7页
目的:以抗体偶联小分子药物(ADC)HS630为例,探讨多变量数据分析(MVDA)在生物药制剂处方稳健性研究中的应用。方法:采用5因子2水平的部分析因设计,考察蛋白质含量、3种辅料含量及pH值对关键质量属性的影响规律。各组制剂样品制备后分别... 目的:以抗体偶联小分子药物(ADC)HS630为例,探讨多变量数据分析(MVDA)在生物药制剂处方稳健性研究中的应用。方法:采用5因子2水平的部分析因设计,考察蛋白质含量、3种辅料含量及pH值对关键质量属性的影响规律。各组制剂样品制备后分别置于高温条件下28 d和光照条件下10 d,进行多聚体含量和游离DM1含量检测和结果分析。结果:采用偏最小二乘法(PLS)进行模型拟合和数据分析,模型拟合良好,预测性能尚可。处方中各辅料和pH的变异对多聚体含量和游离DM1含量均无显著影响。蛋白质含量和pH的升高会在一定限度上增加冻干制剂中游离DM1的含量,但影响并不显著。光照和高温对各处方均有显著影响,但影响趋势一致且整体变化幅度不大。本研究范围内制剂处方稳健。结论:采用MVDA方法进行生物药制剂稳健性研究,可以对不同处理条件获得的多维数据进行分析,识别关键制剂组分,并考察处理条件对关键质量属性的影响。 展开更多
关键词 多变量数据分析 生物药制剂 处方稳健性
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Control Effect of Four Kinds of Agents for Anthracnose in Autumn Greenhouse Cowpea
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作者 彭昌家 白体坤 +5 位作者 丁攀 冯礼斌 刘怡欣 杨宇衡 朱成 陈丹 《Agricultural Science & Technology》 CAS 2016年第10期2324-2328,共5页
In order to mitigate the occurrence and damage of cowpea anthracnose and reduce the chemical pesticide consumption, residue and environmental pollution, the methods of forecasting, randomized block design and statisti... In order to mitigate the occurrence and damage of cowpea anthracnose and reduce the chemical pesticide consumption, residue and environmental pollution, the methods of forecasting, randomized block design and statistical analysis were conducted to study the control effect of biopesticide chitosan, biochemical compound Prochloraz-Chitosan and chemical pesticides difenoconazole and thifluzamide by field efficacy trials. The results showed that under serious occurrence of anthracnose in autumn greenhouse cowpea, when the 2% chJtosan AS (2 250 g/hm^2), 46% Prochloraz-Chitosan EW (450 g/hm^2), 10% difenoconazole WG (900 g/hm^2, CK) or 24% thifluzamide SC (360 ml/hm^2) were applied three times with an interval of 5-8 d, the control efficiency on day 7, 14 and 20 reached 83%, 78% and 73%, respectively. No significant difference was found in control efficiency among the four kinds of agents. These four kinds of agents, especially chitosan and Prochloraz-Chitosan, could be used as ideal agents for controlling anthracnose, as well as for modern agricultural demonstration zones, pollution-free agricultural products, green agricultural products and organic agricultural products,thereby meeting the develop- ment needs of 'modern agriculture, green agriculture, organic agriculture and ecological agriculture. 展开更多
关键词 Cowpea anthracnose Biopesticide CHITOSAN Biochemical compound Prochloraz-Chitosan Chemical pesticide DIFENOCONAZOLE THIFLUZAMIDE Control efficacy
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Eggs as a Very Promising Source of Biomedical and Nutraceutical Preparations: A Review
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作者 Tadeusz Trziszka Henryk Rozanski Antoni Polanowski 《Journal of Life Sciences》 2013年第8期862-877,共16页
It is generally accepted that eggs besides being a source of everyday diet, can also be used as raw material for special food, nutraceutical, pharmaceutical and cosmetic production. The biological activity of the majo... It is generally accepted that eggs besides being a source of everyday diet, can also be used as raw material for special food, nutraceutical, pharmaceutical and cosmetic production. The biological activity of the majority of substances presented in egg matter is related to their anti-microbial and anti-cancer properties and their immunogenic features as well. Due to the use of new generation of feed additives and techniques of immunisation of hens, the chemical composition and biological features of eggs may be modified and enriched with desired components, like n-3 fatty acids (alpha-linolenic acid (ALA), docosahexaenoic acid (DHA) phospholipids), vitamins, microelements. Egg material may also be used for the production of new biopreparations for the prophylaxis of various civilisation diseases, such as heart and cardiovascular diseases, cancers, neurogenerative disorders, metabolic bone diseases etc.. New progress in egg science allowed to discover new bioactive substances, like monomeric and dimeric cystatin and yolkin. It is necessary to develop efficient methods of isolation of biologically active substances contained in eggs, which would make it possible to produce new generation of diet supplements and biomedical products. It seems that new generation of eggs could be the best source for production of natural, high value nutraceutical supplements of diet, and also biomedical and biocosmetic preparations. 展开更多
关键词 Chicken egg ovoalbumin LYSOZYME IMMUNOGLOBULIN yolkin phospholipids.
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In Vivo Anti-Inflammatory Assessment of Quillaja saponaria Mol. Extracts
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作者 Mait6 Rodriguez-Diaz Olosmira Correa +2 位作者 Carlos Cartagen Bruce K. Cassels CarlaDelporte 《Journal of Life Sciences》 2013年第12期1243-1248,共6页
Aqueous extracts from the native Chilean Quillaja saponaria tree are used orally and topically to treat lung inflammatory problems and toothache. This study aimed to corroborate their presumed anti-inflammatory activi... Aqueous extracts from the native Chilean Quillaja saponaria tree are used orally and topically to treat lung inflammatory problems and toothache. This study aimed to corroborate their presumed anti-inflammatory activity, identify their active ingredients and validate their use. The topical anti-inflammatory activity of a commercial partially purified Quillaja saponin aqueous extract (Ultra Dry 100Q, UD), the crude acid hydrolysate (H-100Q) of this material, its two most abundant sapogenins QA (quillaic acid) and PA (phytolaccagenic acid), and two formulations containing QA were subjected to topical assays for the inhibition ofmurine ear inflammation elicited by AA (arachidonic acid) or TPA (phorbol ester). The dose-dependent anti-inflammatory activity of QA was confirmed in both AA (maximal effect 92.1%) and TPA (maximal effect 62.2%) assays, and PA showed significant anti-inflammatory activity against AA (46.5%). Two dermo pharmaceutical formulations containing 8% w/v QA as the active ingredient--a cream and a gel--also exhibited significant anti-inflammatory effects in the TPA (50.8%) and AA (39.5%) assays. 展开更多
关键词 Quillaja saponaria TRITERPENOIDS quillaic acid phytolaccagenic acid topical anti-inflammatory activity phorbol acetate arachidonic acid.
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Antiangiogenic agents combined with chemotherapy in non-small cell lung cancer
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作者 Shanshan Chen Shun Lu 《The Chinese-German Journal of Clinical Oncology》 CAS 2015年第2期58-64,共7页
As a targeted therapy, antiangiogenic treatment has been increasingly studied for advanced non-small cell lung cancer(NSCLC) and has proven effective for the treatment of advanced NSCLC. Bevacizumab, a monoclonal anti... As a targeted therapy, antiangiogenic treatment has been increasingly studied for advanced non-small cell lung cancer(NSCLC) and has proven effective for the treatment of advanced NSCLC. Bevacizumab, a monoclonal antibody targeting angiogenesis, is the only antiangiogenic agent approved for use in combination with first-line chemotherapy for non-squamous NSCLC. Small-molecule inhibitors targeting the tyrosine kinase receptor have also shown promise when combined with standard chemotherapeutic agents in patients with advanced NSCLC. However, unlike bevacizumab, not all other antiangiogenic agents show significant benefits when combined with chemotherapy. As for the failures of most other combinations, the combination schedule may be an important reason that has so far been overlooked in clinical trials. This article reviews the combination of angiogenic agents with chemotherapy in the treatment of NSCLC. 展开更多
关键词 non-small cell lung cancer (NSCLC) antiangiogenic agent CHEMOTHERAPY combination schedule
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