肺部给药国内外研究进展

本文综述了近年来国内外肺部给药系统的研究进展,特别是国内蛋白质和肽类的肺部给药剂型研究。     

茵陈五苓散对大鼠酒精性肝损伤防治作用的研究

目的观察茵陈五苓散对大鼠酒精性肝损伤血清ALT、AST和病理组织学的影响，为临床酒精性肝损伤的防治提供实验依据。方法采用白酒灌胃造模，50只Wistar大鼠随机分成正常组、模型组、预防1组、预防2组、治疗组，分别于实验第5周、第9周末尾静脉取血，分离血清，测定ALT、AST。并于第9周取血后肝脏取材，常规HE染色，光镜观察。结果模型组血清ALT、AST明显升高，预防1、2组、治疗组血清ALT、AST均低于模型组，差异具有显著性（均P〈0．01）。模型组成功建立酒精性肝损伤病理学模型，预防组、治疗组病理学改变较模型组显著减轻。结论茵陈五苓散能有效地预防和治疗大鼠酒精性肝损伤。     

注射用熊胆粉及其原料熊胆粉指纹图谱研究

目的:建立注射用熊胆粉及其原料熊胆粉指纹图谱的分析方法.方法:采用反相高效液相色谱法(RP-HPLC法).色谱柱用Shim-pack VP C18柱(4.0 mm×150 mm,5μm);流动相为甲醇-0.03 mol/L磷酸二氢钠溶液,梯度洗脱;检测波长为210 nm.结果:样品中各成分可得到较好的分离,指纹性较好;方法学考察表明,RP-HPLC法具有较好的重现性;指纹图谱相似度评价相关系数均大于0.9.结论:该指纹图谱可作为熊胆粉、注射用熊胆粉具有专属性的指纹图谱,适于作熊胆粉及其制剂的质量控制方法.     

干粉吸入剂的有效性及质量评价

综述了影响干粉吸入剂有效性的因素,并对其体内外测定方法及质量控制进行了概述.     

反相高效液相色谱法测定益康唑癣粉中硝酸益康唑的含量

目的:建立益康唑癣粉中硝酸益康唑的含量测定方法.方法:采用C18色谱柱,甲醇-水-三乙胺(85 ∶ 15 ∶ 0.1)(冰醋酸调节pH为6.0)为流动相,检测波长为230nm.结果:浓度在0.4147～4.147μg范围内,硝酸益康唑的线性关系良好(r=0.9996),平均回收率为100.2%,RSD为0.53%(n=9).结论:所建含量测定方法可行,操作简便,结果准确,专属性好,可用于控制益康唑癣粉的质量.     

幼泻停敷脐散对IBS-D模型大鼠血清中TNF-α和IL-10含量的影响

目的:探讨幼泻停敷脐散对IBS-D模型大鼠血清中TNF-α和IL-10含量的影响及作用机制。方法:将Wistar大鼠随机分成正常对照组、模型对照组、得舒特组、幼泻停敷脐散高剂量组、幼泻停敷脐散中剂量组、幼泻停敷脐散低剂量组。观察大鼠的活动状况;测定大鼠的小肠运动、血浆中TNF-α和IL-10含量的变化。结果:正常对照组行动活跃、精神良好、皮毛润泽、饮食不减、实验后体重高于实验前,模型各组均出现不同程度的精神萎靡、活动明显减少,大便松散、稀便;幼泻停敷脐散高剂量、中剂量组及得舒特组的小肠运动减慢,与模型组比较有显著性差异,P0.01;幼泻停敷脐散高、中剂量组及得舒特组的TNF-α和IL-10含量降低,与正常组比较,无显著性差异,P0.05,与模型组比较有极显著性差异,P0.01。结论:幼泻停敷脐散能抑制IBS-D模型大鼠的小肠运动和血浆中TNF-α和IL-10含量异常升高,对IBS-D模型大鼠有很好的治疗作用。     

Assessing compressibility and compactibility of powder formulations with Near-Infrared Spectroscopy

Context: The compressibility and compatibility of a powder formulation is usually determined by compaction and following destructive tensile strength and relative density measurement of the final compact.

Objective: In this study, a non-destructive method with Near-Infrared Spectroscopy (NIRS) was designed and evaluated for the measurement of powder compressibility and compactibility.

Materials and Methods: 12 different formulations with a wide range of difference in properties were investigated by compaction and analysis of the resulting tablets. Two similar tablet batches were produced with every formulation. Relative density and tensile strength were measured with the traditional, destructive method on one tablet batch while a newly developed non-destructive chemometric NIRS method was applied for the second batch. The outcomes of the two approaches were compared to validate the developed method. All data sets were applied to three established mathematical equations to calculate equation factors, which are claimed to represent the formulation compressibility and compactibility. The study focus was set on the equation factor value comparison between the traditional and the newly designed method.

Results & Discussion: The results showed a high similarity between the outcomes of the two methods. An essential difference was noticed for the outcomes of the equation factors after application to the Leuenberger equation.

Conclusion: The approach with the NIRS is suggested as a promising tool for a reliable inline quality monitoring in the tablet manufacturing process.     

傅青主保产无忧散的临床应用进展

为了解傅青主保产无忧散的临床应用情况，本文从傅青主保产无忧散的起源、药理作用、临床研究等方面对保产无忧散进行梳理分析，发现保产无忧散有养血、益气、理气的作用。临床上具有防治难产，治疗多种原因导致的先兆流产、早产，可将晚期妊娠臀位、横位转为头位以利于阴道分娩，对过期妊娠有一定的催引产效果，对于妊娠期特发性黄疸、肝功能异常等妊娠期并发症有防治作用，还可用于治疗胃脘痛，配合针刺促卵泡发育治疗女性不孕症，值得进一步研究。     

Qianzheng powder for the treatment of primary Hemifacial spasm: A protocol for systematic reviews and meta-analysis

Background:Hemifacial spasm (HFS) is a clinical common neurological disease, its main performance for 1 side or 2 sides muscles (the orbicularis oculi muscle, expression, orbicularisoris muscles) recurrent paroxysmal, involuntary twitching, aggravating when excited or nervous, more severe cases of the disease may include difficulty in opening the eyes, crooked corners of the mouth, and twitching noises in the ears, etc.^[1] Early manifestations of the disease are intermittent mild convulsions of the orbicularis oculi muscle, and then gradually spread to 1 side of the facial muscles, such as frowning muscles, nasal muscles, buccinalis muscles, etc, especially the most obvious spasms of the oral muscles, which can involve the ipsilateral platysma muscle in severe cases, with each twitch for a few seconds to a few minutes. The disease will affect the quality of life such as speaking, eating, seeing and so on, and even cause psychological effects such as inferiority, anxiety and depression. At present, the incidence of the disease in China is 11 per 1.1 million, females are more common than males. There are many ways to treat HFS, but the Qianzheng powder has a unique advantage in treating this disease. Therefore, our systematic review aims to evaluate the efficacy and safety of Qianzheng powder in the treatment of Primary Hemifacial spasm, and to provide a reliable basis for clinical decision makers.Methods:From its inception until April 2021, we will search electronic databases, including PubMed, Embase, Cochrane Library, China Biomedical Literature Database, China Knowledge Infrastructure, Wanfang Database, and China Scientific Journals Database. The authors will independently sift through studies, extract data information, and assess methodological quality using the Cochrane Risk of Bias tool. The RevManV. 5.3 software will be used for statistical analysis.Results:The results of this study, which will be published in a peerreviewed journal, will evaluate the efficacy and safety of Qianzheng powder in the treatment of primary Hemifacial spasm.Conclusion:This systematic review will provide reliable evidence-based basis for treating primary Hemifacial spasm with Qianzheng powder.INPLASY Registration number:INPLASY202130037.