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The Role of Pro-Inflammatory Mediator Interleukin-32 in Osteoclast Differentiation. 促炎介质白细胞介素-32在破骨细胞分化中的作用。
IF 1.7 Pub Date : 2023-05-09 DOI: 10.4274/tjps.galenos.2022.69922
Taha Nazir, Nida Taha, Azharul Islam, Ishtiaq Rabbi, Pervaiz Akhter Shah

The recently explained cytokine, which is produced after the stimulation of interferon (IFN)-c, interleukin (IL)-2, and IL-18 is IL-32, has pro-inflammatory IFN-c, IL-2 and IL-18 are IL-32 mediator's properties that are generally entailed in many diseases, including infections, cancer, and chronic inflammation. After the initial statement in 2005, it promoted the osteoclast precursor's differentiation into TRAcP plus VNR plus multinucleated cells that express explicit osteoclast indicators. Furthermore, the loss of bone resorption might be accredited because of the collapse of the multinucleated cells, which are produced of the reaction to IL-32 to direct factoring that is ultimately essential for attaching the cells for bone resorption. Thus, in conclusion, IL-32, the pro-inflammatory mediator, has an important and indirect role in regulating osteoclast differentiation. In bone disorder's pathophysiology, critical role of IL-32 needs more scientific evidence to develop a rational treatment protocol. IL-32 can become a potent mediator of active osteoclast generation in the presence of receptor activator of NF-κB ligand (RANKL). This novel cytokine can introduce more favorable conditions for osteoclastogenesis in the rheumatic arthritis by increasing the RANKL and osteoprotegerin ratio in fibroblast-like synoviocytes.

最近解释的细胞因子是干扰素(IFN)-c、白细胞介素(IL)-2和IL-18刺激后产生的IL-32,具有促炎IFN-c、IL-2和IL-18是IL-32介质的特性,通常涉及许多疾病,包括感染、癌症和慢性炎症。2005年初始声明后,促进破骨细胞前体分化为表达明确破骨细胞指标的TRAcP + VNR +多核细胞。此外,骨吸收的丧失可能是由于多核细胞的崩溃,多核细胞是与IL-32反应产生的,以直接分解,这是最终附着细胞进行骨吸收所必需的。综上所述,IL-32作为促炎介质在调节破骨细胞分化中具有重要的间接作用。在骨疾病的病理生理中,IL-32的关键作用需要更多的科学证据来制定合理的治疗方案。在NF-κB配体受体激活剂(RANKL)存在的情况下,IL-32可以成为活性破骨细胞生成的有效介质。这种新的细胞因子可以通过增加成纤维细胞样滑膜细胞的RANKL和骨保护素比例,为风湿性关节炎的破骨细胞形成提供更有利的条件。
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引用次数: 0
Erratum. 勘误表。
IF 1.7 Pub Date : 2023-05-09 DOI: 10.4274/tjps.galenos.2023.48961.e001
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引用次数: 0
Radiolabeling, Quality Control, and Cell Binding Studies of New 99mTc-Labeled Bisphosphonates: 99mTc-Ibandronate Sodium. 新的99mtc标记的双磷酸盐:99mtc -伊班膦酸钠的放射性标记、质量控制和细胞结合研究。
IF 1.7 Pub Date : 2023-05-09 DOI: 10.4274/tjps.galenos.2022.01346
Meliha Ekinci, Derya İlem Özdemir, Emre Özgenç, Evren Gündoğdu, Makbule Aşıkoğlu

Objectives: Early detection of bone cancer is critical for treating symptoms, minimizing pain, and increasing overall quality of life. It is critical to develop novel radiopharmaceuticals with high labeling efficiency and stability for the diagnosis of bone cancer. This research aims to design a novel radiopharmaceutical that may be used to diagnose bone cancer.

Materials and methods: In this study, ibandronate sodium (IBD), a bisphosphonate analog, was radiolabeled with technetium-99m [99mTc] and quality control tests on the newly developed radiopharmaceutical ([99mTc]Tc-IBD) were performed using radioactive thin layer chromatography. After that, the incorporation of [99mTc]Tc-IBD into hydroxyapatite (HA) crystals and a human bone osteosarcoma cell line (U2OS) was tested.

Results: According to the results obtained, optimal radiolabeling procedure was obtained for [99mTc]Tc-IBD with 200 μg.mL-1 IBD, 20 μg stannous chloride, and 99mTc with 37 MBq radioactivity. The reaction mixture was adjusted to pH 5.5 and incubated at room temperature for 15 min. The radiochemical purity of [99mTc]Tc-IBD was found to be greater than 95% at room temperature for up to 6 h. Additionally, chromatography analysis showed >95% [99mTc]Tc-IBD complex formation with promising stability for up to 24 h in saline and up to 2 h in cell medium. The percentage binding of IBD to HA was 83.70 ± 3.67 and the logP of [99mTc]Tc-IBD was -1.1014. The radiolabeled complex exhibited a higher rate of cell incorporation to U2OS cells compared to Reduced/Hydrolyzed 99mTcO4 -.

Conclusion: The newly produced radiopharmaceutical is very promising according to the results of in vitro cell culture, HA binding, and quality studies, and will be a step forward for further studies in nuclear medicine for bone cancer diagnostics.

目的:早期发现骨癌对于治疗症状、减少疼痛和提高整体生活质量至关重要。开发具有高标记效率和稳定性的新型放射性药物是骨癌诊断的关键。本研究旨在设计一种可能用于诊断骨癌的新型放射性药物。材料与方法:本研究以双膦酸盐类似物伊班膦酸钠(IBD)为研究对象,采用锝-99m [99mTc]进行放射性标记,并采用放射性薄层色谱法对新研制的放射性药物([99mTc]Tc-IBD)进行质量控制检测。然后,将[99mTc]Tc-IBD掺入羟基磷灰石(HA)晶体和人骨骨肉瘤细胞系(U2OS)中进行检测。结果:根据所得结果,获得了以200 μg对[99mTc]Tc-IBD进行放射性标记的最佳方法。mL-1 IBD, 20 μg氯化亚锡,99mTc, 37 MBq放射性。将反应混合物调至pH 5.5,在室温下孵育15分钟。发现[99mTc]Tc-IBD在室温下的放射化学纯度大于95%,最长可达6小时。此外,色谱分析表明,[99mTc]Tc-IBD复合物形成>95%,在生理盐水中可达24小时,在细胞培养基中可达2小时。IBD与HA结合的百分比为83.70±3.67,[99mTc]Tc-IBD的logP为-1.1014。与还原/水解99mTcO4 -相比,放射性标记复合物与U2OS细胞的结合率更高。结论:从体外细胞培养、透明质酸结合和质量研究结果来看,新研制的放射性药物具有广阔的应用前景,将为核医学在骨癌诊断方面的进一步研究迈出重要一步。
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引用次数: 0
Use of Herbal Tea/Herbal Preparations for Children with Symptoms of Viral Upper Respiratory Infections. 使用凉茶/草药制剂治疗病毒性上呼吸道感染患儿。
IF 1.7 Pub Date : 2023-03-02 DOI: 10.4274/tjps.galenos.2022.65475
Methiye Mancak Karakuş, Anıl Tapısız, Nazmi Mutlu Karakaş, Melis Deniz, Ufuk Koca Çalışkan

Objectives: Respiratory tract infections (RTIs) are common in children. To treat the symptoms of simple health problems, individuals look for natural healing methods that can be easily prepared at home. The aim of this study was to determine the plants and herbal products used by the parents of children suffering from viral upper respiratory tract symptoms by questionaire. In the study, applications and products, other than plants used by families for their children were also investigated.

Materials and methods: This study is a cross-sectional survey conducted at Faculty of Medicine, Gazi University (Ankara, Türkiye). A questionnaire form was used by scanning the existing literature and reviewed with the patients face to face by the researchers. The data obtained from the study were analyzed with the Statistical Package for the Social Sciences (SPSS) statistical program.

Results: About half of the participants reported that they used non-chemical drug practices for their children with upper RTIs. The most common practice was to prepare herbal tea (30.5%), followed by mandarin/orange and/or their juice (26.9%) for oral application. The most used herbal tea for upper RTIs is with linden (Tilia sp.). Patients who used linden usually prepared it as tea, in other words by infusion, and served their children 1-2 cups/1-3 times a week. Except for herbal tea, the participants mostly used honey (19.0%) for their children's symptoms.

Conclusion: Where available, appropriate doses and dosage forms of herbal supplement products with scientifically proven efficacy and safety should be determined for the pediatric population. Parents should use these products based on the recommendations of their pediatrician.

目的:呼吸道感染(RTIs)在儿童中很常见。为了治疗简单的健康问题的症状,人们寻找可以在家里轻松准备的自然治疗方法。本研究的目的是通过问卷调查确定患有病毒性上呼吸道症状的儿童的父母使用的植物和草药产品。在这项研究中,除了植物之外,家庭为孩子使用的应用和产品也被调查了。材料和方法:本研究是在Gazi大学(Ankara, trkiye)医学院进行的横断面调查。研究人员通过浏览现有文献,与患者面对面进行问卷调查。从研究中获得的数据用社会科学统计软件包(SPSS)统计程序分析。结果:大约一半的参与者报告说,他们使用非化学药物的做法为他们的孩子上呼吸道感染。最常见的做法是制备凉茶(30.5%),其次是柑橘/橙子和/或其果汁(26.9%)用于口服。上呼吸道感染最常用的草药茶是椴树(椴树属)。使用菩提树的患者通常将其制成茶,换句话说,通过输液,并为他们的孩子提供1-2杯/每周1-3次。除花草茶外,参与者大多使用蜂蜜(19.0%)来治疗孩子的症状。结论:在可行的情况下,应该为儿科人群确定科学证明有效和安全的草药补充剂产品的适当剂量和剂型。家长应根据儿科医生的建议使用这些产品。
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引用次数: 2
In Vitro Anti-Leishmanial Activity of Glucosinolate Fraction from Alyssum linifolium Steph. ex Willd (Brassicaceae). 茜草硫代葡萄糖苷部分体外抗利什曼原虫活性研究。前野生(芸苔科)。
IF 1.7 Pub Date : 2023-03-02 DOI: 10.4274/tjps.galenos.2022.78027
Fatemeh Mirzaee, Roghiyeh Faridnia, Mahdi Fakhar, Hamed Kalani, Somayeh Shahani

Objectives: The intracellular parasitic protozoan, Leishmania spp., causes several forms of diseases in humans. Cytotoxicity and emergence of new strains resistance to the current anti-leishmanial drugs have encouraged researchers to focus on new resources. Glucosinolates (GSL) are found mainly in the Brassicaceae family with potential cytotoxic and anti-parasitic properties. The present study reports in vitro antileishmanial activity of the GSL fraction from Alyssum linifolium seeds against Leishmania major.

Materials and methods: The GSL fraction was prepared by ion-exchange and reversed-phase chromatography. For the assessment of antileishmanial activity, the promastigotes and amastigotes of L. major were treated with different concentrations of the fraction (75-625 μg/mL).

Results: The IC50 was 245 µg/mL for anti-promastigote effect of the GSL fraction and 250 µg/mL for its anti-amastigote effect that had a significant difference (p<0.05) with both glucantime and amphotericin B. The selectivity index of the GSL fraction (15.8), to glucantime and amphotericin B, was greater than 10, indicating the selective effect of this fraction against L. major amastigotes. Glucoiberverin was the major constituent of the GSL fraction characterized using nuclear magnetic resonance and electron ionization-mass spectrometry spectra. Based on gas chromatography-mass spectrometry data, iberverin and iberverin nitrile, the hydrolysis constituents from glucoiberverin, included 76.91% of the total seed volatiles.

Conclusion: The results suggest that GSLs like glucoiberverin could be considered a new promising candidate for further studies on antileishmanial activity.

目的:细胞内寄生原生动物利什曼原虫引起人类多种疾病。细胞毒性和对当前抗利什曼药物产生耐药性的新菌株的出现促使研究人员将重点放在新的资源上。硫代葡萄糖苷(Glucosinolates, GSL)主要存在于十字花科植物中,具有潜在的细胞毒和抗寄生特性。本研究报道了Alyssum linifolium种子GSL部分对利什曼原虫的体外抗利什曼原虫活性。材料和方法:采用离子交换-反相色谱法制备GSL馏分。采用不同浓度的提取物(75 ~ 625 μg/mL)处理大黄乳杆菌原毛菌和无尾毛菌,考察其抗利什曼原虫活性。结果:GSL部位抗promastigote作用的IC50为245µg/mL,其抗amastigote作用的IC50为250µg/mL,两者具有显著性差异(pL. major amastigotes)。利用核磁共振和电子电离质谱分析对GSL部分的主要成分进行了表征。气相色谱-质谱分析结果表明,从葡萄籽中提取的水解成分——鸢尾素和鸢尾素腈占总挥发物的76.91%。结论:GSLs类糖维苷可作为抗利什曼原虫活性进一步研究的新候选物。
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引用次数: 0
Investigation of Antimicrobial Activity of Some Ethylparaben Hydrazide-Hydrazone Derivatives. 对羟基苯甲酸乙酯酰腙衍生物的抗菌活性研究。
IF 1.7 Pub Date : 2023-03-02 DOI: 10.4274/tjps.galenos.2022.57699
Ufuk İnce, M İhsan Han

Objectives: The development of antimicrobial molecules discussed with considerable achievement over the past decades provided many classes of semisynthetic or synthetic compounds. Resistance to many antimicrobial agents requires the discovery of novel molecules.

Materials and methods: In this study, ten ethylparaben hydrazide-hydrazone derivatives, the previously reported, were evaluated for their in vitro antibacterial and antifungal activities. The microbroth dilution method was used for the determination of the minimum inhibitory concentration (MIC) values of the novel molecules.

Results: The antimicrobial activities of the molecules were found in a wide range with MIC values of 2-256 μg/mL. The synthesized compounds showed good to moderate antimicrobial activity compared with the standards. Among the synthesized molecules, compound 3g showed the best antimicrobial activity at 2 μg/mL against Staphylococcus aureus strain (ATCC 29213).

Conclusion: Ethylparaben hydrazide-hydrazone compounds in our study were found to have antimicrobial activities. Ethylparaben is currently used as an antibacterial agent and preservative for preparations. These studies are necessary since they detect the relationship between the substitutions and activity.

目的:在过去的几十年里,抗菌分子的发展取得了相当大的成就,提供了许多类别的半合成或合成化合物。对许多抗菌剂的耐药性需要发现新的分子。材料与方法:对已报道的10种对羟基苯甲酸乙酯酰腙衍生物进行体外抗菌和抗真菌活性评价。采用微肉汤稀释法测定新分子的最低抑菌浓度(MIC)。结果:各分子的抑菌活性范围广,MIC值为2 ~ 256 μg/mL。与标准化合物比较,合成的化合物具有良好至中等的抗菌活性。在所合成的分子中,化合物3g对金黄色葡萄球菌(ATCC 29213)的抑菌活性在2 μg/mL时表现最佳。结论:本研究发现对羟基苯甲酸乙酯酰腙类化合物具有抗菌活性。对羟基苯甲酸乙酯目前用作制剂的抗菌剂和防腐剂。这些研究是必要的,因为它们检测了取代和活性之间的关系。
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引用次数: 0
Development and Validation of SI/RS-UHPLC-PDA Method for Olmesartan Medoxomil and Metoprolol Succinate-Related Substance. 奥美沙坦酯和琥珀酸美托洛尔相关物质的 SI/RS-UHPLC-PDA 方法的开发与验证
IF 1.8 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2023-03-02 DOI: 10.4274/tjps.galenos.2022.57384
Nirmal Thakker, Gajanan Shinde, Abhay Dharamsi, Vishnu Choudhari

Objectives: Olmesartan medoxomil (OLM) and metoprolol succinate (MPS) in fixed-dose combination (FDC) tablet formulation prescribed extensively. Stability indicating (SI) method for impurities and related substance (RS) test quantitates the amount of these analytes in formulation; the manuscript presents SI/RS-ultra-high performance liquid chromatography-photodiode array (UHPLC-PDA) method for OLM and MPS and their impurities.

Materials and methods: Well-resolved separation of all analytes was achieved with gradient elution on a Shimadzu on Shimpack GIST-C18 (100 mm x 2.1 mm, 2 µm) column maintained at 25°C. Mobile phase-A consist of 0.1% orthophosphoric acid in water and mobile phase-B was acetonitrile at a flow rate of 0.4 mL/min, data integrated at 225 nm and 16 min of short runtime for satisfactory elution of all peaks.

Results: The proposed SI/RS-UHPLC-PDA method was developed and validated as per International Conference on Harmonisation (ICH) of Technical Requirements guidelines. The system suitability test complied by all eluted peaks of the interest with acceptable linearity, recovery, and precision. Specificity, robustness, and method sensitivity parameters were determined; all the parameters were found to be within the limits. All the impurities and stress-degraded peaks were well resolved.

Conclusion: The proposed method was found to be simple, fast, linear, and accurate. Further, the method is precise, robust, and specific; suitable for routine IPQC during active pharmaceutical ingredient manufacturing, stability and impurity profiling studies of the titled bulk analytes. Furthermore, the method can be extended to assess the levels of impurities formed during life cycle of new FDCs of titled analytes.

目的:奥美沙坦酯(OLM)和琥珀酸美托洛尔(MPS)在固定剂量复合制剂(FDC)片剂中被广泛使用。杂质稳定性指示(SI)方法和相关物质(RS)测试可定量检测这些分析物在制剂中的含量;本手稿介绍了 OLM 和 MPS 及其杂质的 SI/RS- 超高效液相色谱-光电二极管阵列(UHPLC-PDA)方法:采用岛津 Shimpack GIST-C18 (100 mm x 2.1 mm, 2 µm)色谱柱,在 25°C 下进行梯度洗脱,实现了所有分析物的良好分离。流动相 A 为 0.1%正磷酸水溶液,流动相 B 为乙腈,流速为 0.4 mL/min,在 225 nm 波长下进行数据整合,运行时间为 16 分钟,所有色谱峰均得到满意的洗脱:所提议的 SI/RS-UHPLC-PDA 方法是根据国际协调会议(ICH)的技术要求指南开发和验证的。所有洗脱峰均符合系统适用性测试的要求,线性、回收率和精密度均可接受。测定了特异性、稳健性和方法灵敏度参数,发现所有参数都在限值之内。所有杂质和应力降解峰都得到了很好的分辨:结论:所提出的方法简单、快速、线性、准确。此外,该方法还具有精确、稳健和特异性的特点,适用于活性药物成分生产过程中的常规 IPQC、稳定性和有标题的散装分析物的杂质分析研究。此外,该方法还可扩展用于评估有标分析物新 FDC 生命周期中形成的杂质水平。
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引用次数: 0
Knowledge Assessment During the Medication Process Use by Older Patients on Clinical Routine: A Pilot Study. 老年患者临床常规用药过程中的知识评估:一项初步研究。
IF 1.7 Pub Date : 2023-03-02 DOI: 10.4274/tjps.galenos.2022.85054
Margarida Espírito-Santo, Tânia Nascimento, Ezequiel Pinto, M Dulce Estêvão

Objectives: The consumption of medicines has been increasing over the last decades. The lack of medication knowledge (MK) may affect the process of medication use and, consequently, may lead to negative health outcomes. This study carried out a pilot study using a new tool to assess MK in older patients in a daily clinical practice.

Materials and methods: An exploratory cross-sectional study was conducted, including older patients (≥65 years), taking two or more medicines, followed in a regional clinic. Data were collected during a structured interview, which included an algorithm for assessing MK regarding the identification of the medicines and its use and storage conditions. Health literacy and treatment adherence were also assessed.

Results: The study enrolled 49 patients, mainly between 65 and 75 years (n: 33; 67.3%) and polymedicated (n: 40; 81.6%), taking a mean of 6.9 ± 2.8 medicines per day. A lack of MK (score <50%) was observed in 15 (30.6%) participant patients. "Drug strength" and "storage conditions" were the items which presented the lowest score. MK was positively correlated with higher scores for health literacy and treatment adherence. Younger patients (age <65 years old) also had a higher MK score.

Conclusion: This study showed that the applied tool could evaluate the MK of the participants and identified specific gaps regarding MK within the process of medicine use. Further studies, with more participants, will allow the confirmation of these findings and will stimulate the development of specific strategies to improve MK, thus contributing to better health outcomes.

目的:在过去的几十年里,药品的消费量一直在增加。缺乏药物知识可能会影响药物使用过程,从而可能导致负面的健康结果。本研究开展了一项试点研究,在日常临床实践中使用一种新的工具来评估老年患者的MK。材料和方法:我们进行了一项探索性的横断面研究,纳入了在一家地区诊所服用两种或两种以上药物的老年患者(≥65岁)。数据是在结构化访谈中收集的,其中包括一种算法,用于评估关于药物鉴定及其使用和储存条件的MK。还对卫生知识普及和治疗依从性进行了评估。结果:该研究纳入了49例患者,主要年龄在65 - 75岁之间(n: 33;67.3%)和多药(n: 40;81.6%),平均每天服用6.9±2.8个药物。结论:本研究表明,所应用的工具可以评估参与者的MK,并识别出药物使用过程中MK的具体差距。有更多参与者参与的进一步研究将能够证实这些发现,并将促进制定具体战略,以改善MK,从而促进更好的健康结果。
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引用次数: 0
Folate-Mediated Paclitaxel Nanodelivery Systems: A Comprehensive Review. 叶酸介导的紫杉醇纳米递送系统:全面综述。
IF 1.7 Pub Date : 2023-03-02 DOI: 10.4274/tjps.galenos.2021.26529
Ashwini K Bawankule, Amol A Tatode, Pranali S Patil, Milind J Umekar

Paclitaxel (PTX) is used as a viable cancer medication in the chemotherapy of breast, ovarian, lung, bladder, neck, head, and esophageal tumors. The focus of this review is to survey various folate-targeting PTX-loaded nanopreparations in both research and clinical applications. There are diverse nanopreparations, including liposomes, micelles, polymeric nanopreparations, lipid nanopreparations, lipoprotein nanocarriers, and other inorganic nanopreparations for folate-associated PTX tumor targeting. Here, the folate targeting PTX-loaded nanopreparations, which have promising results in the constructive treatment of cancer by reducing toxic side-effects and/or improving effectiveness, was mainly reviewed.

紫杉醇(PTX)是一种可行的癌症药物,用于乳腺、卵巢、肺、膀胱、颈部、头部和食道肿瘤的化疗。本文综述了各种叶酸靶向ptx负载纳米修复剂的研究和临床应用。有多种纳米修复,包括脂质体、胶束、聚合物纳米修复、脂质纳米修复、脂蛋白纳米载体和其他针对叶酸相关PTX肿瘤的无机纳米修复。本文主要综述了叶酸靶向ptx负载纳米修复剂,这些纳米修复剂通过减少毒副作用和/或提高疗效,在癌症的建设性治疗中有很好的结果。
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引用次数: 2
Stability Evaluation of the Biosimilar Monoclonal Antibody Using Analytical Techniques. 生物类似药单克隆抗体稳定性分析技术评价。
IF 1.7 Pub Date : 2023-03-02 DOI: 10.4274/tjps.galenos.2022.47690
Deniz Demirhan
ObjectivesDetermination of the drug substance (DS) and drug product (DP) stability is especially important for biosimilar monoclonal antibodies since it can affect the quality, efficacy, and safety of the drugs. The main objective of this study was to determine the stability of the biosimilar candidate (TUR01) using state-of-the-art (current) analytical techniques.Materials and MethodsAnalytical techniques used in this study were isoelectric focusing on capillary electrophoresis, capillary electrophoresis-sodium dodecyl sulfate, size exclusion chromatography-ultra-high performance liquid chromatography, binding affinity, and physicochemical and microbiological tests. DS was kept in polyethylene terephthalate copolyester, glycol modified (PETG) bottles at ≤-65.0°C and 5.0 ± 3.0°C for 18 months, where the pre-filled syringe stability study was conducted at 5.0 ± 3.0°C for 24 months and 25.0 ± 2.0°C/60% ± 5 relative humidity (RH) for 6 months. The accelerated condition for DS was accepted as 5.0 ± 3.0°C, while it was 25.0 ± 2.0°C for the DP.ResultsThe results indicated that TUR01 DS was stable when it was stored under long-term storage conditions at ≤-65°C and at 5 ± 3°C at least 18 months. Also, TUR01 DP was stable at 5 ± 3°C for 24 months and at 25 ± 2°C with 60.5% RH for 2 months without any significant changes.ConclusionState-of-the-art analytical techniques proved to be invaluable tools for evaluate the stability of the TUR01 DS and drug product.
目的:原料药(DS)和制剂(DP)稳定性的测定对单克隆生物仿制药的质量、疗效和安全性具有重要意义。本研究的主要目的是利用最新的分析技术确定候选生物类似药(TUR01)的稳定性。材料和方法:本研究使用的分析技术为毛细管电泳等电法、毛细管电泳-十二烷基硫酸钠法、粒径排除色谱-超高效液相色谱法、结合亲和法、理化和微生物学试验。DS在≤-65.0℃和5.0±3.0℃的聚对苯二甲酸乙二醇改性(PETG)瓶中保存18个月,其中在5.0±3.0℃下保存24个月,在25.0±2.0℃/60%±5相对湿度(RH)下保存6个月。DS的加速条件为5.0±3.0℃,DP的加速条件为25.0±2.0℃。结果:结果表明,TUR01 DS在≤-65℃和5±3℃条件下长期保存至少18个月,表现稳定。TUR01 DP在5±3°C条件下稳定24个月,在25±2°C条件下稳定2个月,RH为60.5%,无明显变化。结论:最先进的分析技术被证明是评估TUR01 DS和药品稳定性的宝贵工具。
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引用次数: 0
期刊
Turkish Journal of Pharmaceutical Sciences
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