甘草种子与种苗质量分级标准研究

目的:研究甘草种子、种苗质量分级标准,为甘草药材规范化生产奠定基础。方法:以全国主产区所流通的甘草种子、种苗为样本,通过收集种子的发芽率、净度、含水量、千粒质量,种苗的根长、芦头直径和百株质量等指标信息,采用K-均值聚类分析法、标准差法、平均值法并结合生产实践对甘草种子、种苗进行分级,并开展田间栽培比较试验,对等级划分的合理性进行验证。结果:甘草种子质量等级划分为3个等级,各级甘草种子的千粒质量不低于8 g,含水量不低于10%,一级种子:发芽率≥90%,净度≥90%;二级种子:90%>发芽率≥85%,90%>净度≥85%;三级种子:85%>发芽率≥80%,85%>净度≥80%。甘草种苗质量等级划分为3个等级,一级种苗:根长≥45 cm,芦头直径≥0.8 cm,1.3 kg≤百株质量<0.8 kg;二级种苗:45 cm>根长≥35 cm,0.8 cm>芦头直径≥0.6 cm,0.8 kg≤百株质量<0.4 kg;三级种苗:35 cm>根长≥25 cm,0.6 cm>芦头直径≥0.4 cm,0.4 kg≤百株质量≤0.2 kg。结论:经验证,甘草种子、种苗质量等级划分合理,便于生产实践应用。     

中成药欧盟注册分析

自2004年起，欧盟和美国分别发布了《传统植物药注册程序指令》和《植物药产品指南》，掀起了中药的新篇章，西方发达国家第一次在法律层面上认可中药作为药品的地位，现通过对欧盟植物药注册法规法律的探讨以及注册成功案例的分析，为我国中成药国际化注册提供一定参考。     

TLC法对众生丸中蒲公英成分的快速鉴别

目的为建立众生丸中蒲公英成分的快速定性鉴别方法,采用薄层色谱法(TLC),基于样品与标准品对照,实现快速定性鉴别。方法通过参考有关文献,经过实验,对众生丸中蒲公英成分的提取方法、提取时间、提取溶剂、展开剂的选择、显色剂的选择对实验结果的影响进行研究。结果以乙酸乙酯为溶剂经超声提取、以三氯甲烷为展开剂,喷以10%硫酸乙醇溶液作为显色剂。薄层色谱鉴别斑点清晰,阴性对照无干扰。结论所建立方法操作简单,具有速度快,分离效果、专属性和重现性好的优点,应用于众生丸中蒲公英成分的快速定性鉴别,可加强对众生丸的质量控制。     

经典名方物质基准研制的关键技术分析

中药经典名方开发已成为当下中医药界研究的热点之一,而其中经典名方物质基准的成功研制对于整个中药经典名方的申报极为关键。经典名方物质基准既是检测经典名方制剂质量的基准,同时又需反映整方的物质基础。中药成分众多而复杂,单成分的、化药式的研发与质量控制模式难以适用于整体药用的中药制剂的开发,亟需开辟一条中药专属的研发模式。以目前已有的现代科学技术,笔者建议将中药的遗传多态性、提取动力学、指纹图谱总量统计矩(相似度)法、超分子"印迹模板"等结合应用于经典名方物质基准的研制,探讨中药经典名方物质基准的质量控制技术,以期全面、准确地阐明药材-饮片-物质基准的成分群量值的传递规律,为推进中药经典名方的研制进程提供参考。     

黔产红土茯苓药材质量标准初步研究

目的:建立黔产红土茯苓药材的质量标准。方法:对不同产地黔产红土茯苓药材进行性状鉴别、显微鉴别、薄层色谱鉴别;参照《中国药典》2015年版四部通则方法对黔产红土茯苓药材水分、总灰分、浸出物进行测定。结果:薄层色谱斑点清晰,分离好,专属性强,无干扰;初步规定黔产红土茯苓药材水分不得过15.0%,总灰分不得过5.0%,水溶性浸出物含量不得少于8.0%。结论:该方法操作简便、结果可靠,能够为黔产红土茯苓药材质量评价提供一定的参考。     

Low-dose l-isoproterenol versus salbutamol in hospitalized pediatric patients with severe acute exacerbation of asthma: A double-blind,randomized controlled trial

BackgroundAlthough the guidelines in most countries do not recommend continuous inhalation of l-isoproterenol to treat pediatric patients with acute severe exacerbation of asthma, lower dose of l-isoproterenol has been widely used in Japan. To determine whether the efficacy of low-dose l-isoproterenol was superior to that of salbutamol, we conducted a double-blind, randomized controlled trial.MethodsHospitalized patients aged 1–17 years were eligible if they had severe asthma exacerbation defined by the modified pulmonary index score (MPIS). Patients were randomly assigned (1:1) to receive inhalation of l-isoproterenol (10 μg/kg/h) or salbutamol (500 μg/kg/h) for 12 hours via a large-volume nebulizer with oxygen. The primary outcome was the change in MPIS from baseline to 3 hours after starting inhalation. Trial registration number UMIN000001991.ResultsFrom December 2009 to October 2013, 83 patients (42 in the l-isoproterenol group and 41 in the salbutamol group) were enrolled into the study. Of these, one patient in the l-isoproterenol group did not receive the study drug and was excluded from the analysis. Compared with salbutamol, l-isoproterenol reduced MPIS more rapidly. Mean (SD) changes in MPIS at 3 hours were −2.9 (2.5) in the l-isoproterenol group and −0.9 (2.3) in the salbutamol group (difference −2.0, 95% confidence interval −3.1 to −0.9; P < 0.001). Adverse events occurred in 1 (2%) and 11 (27%) patients in the l-isoproterenol and salbutamol groups, respectively (P = 0.003). Hypokalemia and tachycardia occurred only in the salbutamol group.ConclusionsLow-dose l-isoproterenol has a more rapid effect with fewer adverse events than salbutamol.     

Synthetic MRI is not yet ready for morphologic and functional assessment of patellar cartilage at 1.5 Tesla

PurposeThe purpose of this study was to compare morphologic assessment and relaxometry of patellar hyaline cartilage between conventional sequences (fast spin-echo [FSE] T2-weighted fat-saturated and T2-mapping) and synthetic T2 short-TI inversion recovery (STIR) and T2 maps at 1.5 T magnetic resonance imaging (MRI).MethodThe MRI examinations of the knee obtained at 1.5 T in 49 consecutive patients were retrospectively studied. There were 21 men and 28 women with a mean age of 45 ± 17.7 (SD) years (range: 18–88 years). Conventional and synthetic acquisitions were performed, including T2-weighted fat-saturated and T2-mapping sequences. Two radiologists independently compared patellar cartilage T2-relaxation time on conventional T2-mapping and synthetic T2-mapping images. A third radiologist evaluated the patellar cartilage morphology on conventional and synthetic T2-weighted images. The presence of artifacts was also assessed. Interobserver agreement for quantitative variables was assessed using intraclass correlation coefficient (ICC).ResultsIn vitro, conventional and synthetic T2 maps yielded similar mean T2 values 58.5 ± 2.3 (SD) ms and 58.8 ± 2.6 (SD) ms, respectively (P = 0.414) and 6% lower than the expected experimental values (P = 0.038). Synthetic images allowed for a 15% reduction in examination time compared to conventional images. On conventional sequences, patellar chondropathy was identified in 35 patients (35/49; 71%) with a mean chondropathy grade of 4.8 ± 4.8 (SD). On synthetic images, 28 patients (28/49; 57%) were diagnosed with patellar chondropathy, with a significant 14% difference (P = 0.009) and lower chondropathy scores (3.7 ± 4.9 [SD]) compared to conventional images. Motion artifacts were more frequently observed on synthetic images (18%) than on conventional ones (6%). The interobserver agreement was excellent for both conventional and synthetic T2 maps (ICC > 0.83). Mean cartilage T2 values were significantly greater on synthetic images (36.2 ± 3.8 [SD] ms; range: 29-46 ms) relative to conventional T2 maps (31.8 ± 4.1 [SD] ms; range: 26-49 ms) (P < 0.0001).ConclusionDespite a decrease in examination duration, synthetic images convey lower diagnostic performance for chondropathy, greater prevalence of motion artifacts, and an overestimation of T2 values compared to conventional MRI sequences.     

Clinical Validation of a Semi-Automated Software for Maximal Diameter Measurements for Endovascular Repair Follow-up

Purpose

To compare automated measurements of maximal diameter (D_max) of abdominal aortic aneurysm (AAA) orthogonal to luminal or outer wall envelope centerline for endovascular repair (EVAR) follow-up.

Hypertensive Crisis during Microwave Ablation of Adrenal Neoplasms: A Retrospective Analysis of Predictive Factors

PurposeTo identify risk factors for hypertensive crisis (HC) during ultrasound-guided percutaneous microwave (MW) ablation of adrenal neoplasms.Materials and MethodsPatients who underwent MW ablation for adrenal tumors between April 2006 and November 2017 were retrospectively identified for this study (51 consecutive patients; 35 males, 16 females; mean age, 55 years; range, 15–85 years). A total of 77 MW ablation treatments were performed for 67 tumors (24 primary [9 pheochromocytomas, 8 adenomas, and 7 cortical carcinomas]; and 43 metastases [22 hepatocellular carcinoma, 8 renal cell carcinoma, 5 non-small cell lung cancer, 4 colorectal cancer, 3 liposarcoma, and 1 malignant fibrous histiocytoma]). The mean diameter of the adrenal tumors was 4.6 cm (range, 1.2–16.2 cm). Information about patient demographics, imaging studies, pathology and laboratory results, procedure records, and clinical outcomes was retrieved and analyzed. Statistical analysis was then performed to determine potential risk factors for HC.ResultsOf the 77 MW ablation procedures, HC occurred in 13 (16.9%). A significantly higher risk of HC was observed in patients with pheochromocytoma (odds ratio [OR], 9.037; 95% confidence interval [CI], 1.731–47.172; P = .009), body mass index <24 kg/m² (OR, 5.167; 95% CI, 1.060–25.194; P = .042), dominant tumor size ≤4.5 cm (OR, 4.023; 95% CI, 1.011–16.005; P = .048), and pre-procedural systolic blood pressure ≥130 mmHg (OR, 0.242; 95% CI, 0.068–0.861; P = .029).ConclusionHC can occur during MW ablation in patients with either primary or metastatic adrenal tumors. Pheochromocytoma, body mass index, tumor size, and pre-procedural systolic blood pressure appear to be significant risk factors for the occurrence of HC.