胰岛素注射器针头在皮下停留的最佳时间分析

糖尿病治疗的具体措施以饮食治疗和适当的体育锻炼为基础,根据不同病情,给予不同的治疗,注射胰岛素是药物治疗中重要的措施之一.我院住院患者调整血糖时大多数使用胰岛素注射器注射胰岛素.临床工作中,按正确皮下注射方法注射胰岛素快速拔针后观察大多有液体从穿刺点溢出,若用棉签压迫穿刺点后拔针,溢出液体被棉签吸收,会误导观察结果,从而使注射的胰岛素剂量不准确,增加调整血糖的难度.我们在使用胰岛素注射器注射胰岛素时发现注射后针头在皮下停留一定的时间减少了液体溢出的可能,随着剂量的增加停留的时间也应相应延长.为此,我们在住院患者应用胰岛素注射器注射胰岛素时,对针头在皮下停留的时间进行了观察,以确定胰岛素剂量在一定范围内时针头在皮下停留的最佳时间.现报道如下.     

注射填充术在颈部年轻化的临床应用进展

颈部衰老是颈部皮肤的慢性进行性老化问题,因其高发生率、低龄化的特征逐渐受到广泛关注.目前国内外治疗方式主要有手术、光电技术、注射填充术、埋线技术及外用药物等,其中注射填充技术是颈部年轻化最常用的手段.该文在分析颈部衰老原因、机制、临床常用分型、分级的同时着重总结目前国内外颈部年轻化临床常用的注射及填充方法进展,以期为颈...     

我院住院患者注射给药情况的调查分析

目的:分析我院住院患者注射给药的使用情况,为注射给药的使用现状和合理用药提供参考.方法:应用军卫一号医院信息系统,调取2011年4月13日我院住院患者的所有医嘱,统计并分析注射剂使用情况.结果:我院住院患者注射给药使用率为71.49%,是临床治疗的主要手段;住院患者抗菌药物使用率40.88%,低于卫生部抗菌药物临床应用监测中心住院病人抗菌药物使用率均值70.10%;经PASS系统审查的不合理用药为26例.结论:我院住院患者注射给药存在部分不合理之处,注射给药的使用现状应当引起重视.     

计算机辅助优选HPLC分析蜀葵属的黄酮类

药蜀葵Althaea officinalis L.的叶、花和根可用于制备抗炎和粘质(mucilaginous)药物。由于组分众多使蜀葵黄酮类的分析困难,因此在预实验中使用Drylab G软件对色谱系统进行了优选。使用梯度洗脱用以除去存在于生物样品中的低极性化合物。 Drylab G软件通过IBM计算机应用。实验使用Hewlett-Packark 1050型液相色谱仪,附有20μl进样器和分光光度检测器。色谱图以3396A记录积分仪在27nm处记录。不锈钢柱,250×4.6mml.D.以7-μm LichrosorbRP-18(E.Merck)用自制设备填充。进样10μl。     

微量注射机在小儿心脏手术中的应用

自1991年以来,我院开展小儿心脏手术近2000例,我们术中使用微量注射机(微量泵)、注射升压药物及扩血管药物维持血压,取得了良好效果。同时注射液体(输液、输血)及麻醉药物,取得了非常满意的效果。通过实践,我们总结出一套简便易行的药物配置方法及使用方法。现将资料完整的200例患儿运用微量泵的体会介绍如下：     

无针注射技术的研究进展

无针注射技术(needle-free injection technology, NFIT)是指药物在压力源作用下形成高速喷射流,透过皮肤到达合适深度的药物递送技术。NFIT可以递送液体、粉末和储库型制剂,具有防止意外针刺伤、提高药物生物利用度、消除针头恐惧、增加疫苗免疫效果、简化操作及易于患者自用等优势,是一种非常有潜力的递送药物方式。本文系统介绍了NFIT的研究背景、无针注射器的结构组成及可递送药物、影响注射效果的因素,并且总结了目前该技术的局限性和发展方向,为NFIT的应用和发展提供理论基础。     

药物制剂中的士的宁和马钱子碱的气液色谱法

本文叙述了在药物液体制剂或片剂中士的宁和马钱子碱的定量分析方法。本法的快速和精密度比以往的分析方法有所改进。实验方法:用氦气作为载气,以3.0%OV-1涂在80～100目Chrom Q作为固定相,填充于硼硅玻璃柱中,柱的外径为0.91米×0.64厘米,层析柱于280℃下恒温,鉴定器及进样注射孔温度为295℃,氦气流速     

胶体液预负荷和晶体液共负荷在预防腰麻剖宫产术中低血压效应的临床疗效对比

目的 比较胶体液预负荷和晶体液共负荷在预防腰麻剖宫产术中低血压效应的临床疗效.方法 选取腰麻剖宫产术的产妇150例,随机分为胶体液预负荷和晶体液共负荷两组.胶体液预负荷组在腰麻前15 min内注射500 mL羟乙基淀粉200/0.5氯化钠注射液;晶体液共负荷组在鞘内注射麻醉时,同时注射1 000 mL乳酸钠林格注射液进行共负荷,当产妇有低血压症状时,注射麻黄碱;记录产妇低血压症状发生概率,麻黄碱使用量,以及术中恶心呕吐情况;新生儿通过Apgars评分,脐静脉血气来分析.结果 胶体液预负荷组和晶体液共负荷组在低血压概率分别为46.7％和45.3％,没有显著性(P＞0.05);麻黄碱使用量和产妇术中恶心呕吐情况,新生儿Apgars评分和脐静脉血气指数没有显著性(P＞0.05).结论 在腰麻剖宫产术中,使用500 mL胶体液预负荷和1 000mL晶体液共负荷在预防低血压症状的临床效果相似,二者都只能降低低血压效应发生率,而不能彻底预防血压效应,应该联合其他血管加压药物才能彻底预防腰麻剖宫产术中低血压效应.     

微量注射泵在神经内科介入术后治疗中的应用

我院自2007年10月以来共开展神经内科介入术24例，ICU担负着术后患者的监护工作。介入术后患者多使用多巴胺、尼莫地平、硝普钠、硝酸甘油等药物维持术后心脑血管循环稳态。术后患者需要控制液体入量，避免因药物浓度波动而产生不良反应。微量注射泵（简称微量泵）是一种用少量液体将药物精确、微量、均匀持续地泵人体内的新型仪器，有单道和双道2种，     

老年糖尿病患者甘精胰岛素SoloStar预填充注射笔的满意度和使用情况研究

目的：本文报告了SUPERSTAR研究的亚组分析,旨在评价年龄≥65岁的中国糖尿病患者对甘精胰岛素（来得时）SoloStar预填充注射笔的满意度和使用情况。方法：一项为期3个月的多中心、观察性、前瞻性登记研究。由医师决定给予SoloStar治疗。基线时收集患者对既往所用注射笔的评价。使用SoloStar注射笔3个月后,收集和分析患者对SoloStar注射笔的满意度和使用情况。结果：共290例老年患者纳入本分析。90.69%的患者使用SoloStar注射笔后评价为＂满意或非常满意＂。多数患者对SoloStar注射笔在社会层面的评价为＂好或很好＂,因为其私密性好、减少公开场合使用的尴尬（75.52%）、减少患者使用胰岛素的障碍（72.76%）和增强患者对胰岛素治疗的信心（71.71%）。绝大多数患者打算继续使用SoloStar注射笔（96.19%）。SoloStar注射笔被认为在10个技术层面上要显著优于既往使用的胰岛素注射笔。结论：中国老年糖尿病患者对SoloStarR注射笔感到满意,并认为其在10个技术层面的可用性更好。     

Determination of conditions for the production scale sterilization of prefilled syringes

External and internal differences in pressure of prefilled syringes can cause plunger movement during sterilization, which might cause drug product contamination. Consequently the pressure inside the autoclave during sterilization should be controlled carefully to prevent contamination of the drug product by microorganism and particulates. A previously determined theoretical relationship of temperature to pressure in sealed bottles was modified for prefilled syringes to take plunger movement into account. This modification yielded a correction factor that includes a coefficient of linear thermal expansion for the syringe, thermal expansion of the plunger, and friction between the plunger and the syringe wall. To confirm the accuracy of this modified relationship, 100 mL polypropylene prefilled syringes with butyl rubber plungers, some of which carried pressure and temperature sensors, were used to test various sterilization conditions at the experimental scale. The results showed that the major problem in establishing the pressure conditions for production scale sterilization is temperature distribution throughout the load. However, an over pressure sterilization cycle at 121 degrees C and 0.34 MPa showed the best results. Microbial challenge and light-obscuration particle count tests were performed on the syringes from the worst-case location predicted from modified relationship; the results show that these conditions preserved the sterility of the drug product and protected it from particulate contamination.     

Heparin administration using prefilled syringes or ampoules: a comparative cost-effectiveness study

Heparin is commonly administered for prophylaxis of thromboembolism in a dose of 5,000iu in 0.2ml subcutaneously twice or three times daily. The presentation may be as a prefilled syringe or as an ampoule. The effect of the presentation on nursing time and the true costs involved has been studied in two London hospitals. Thirty-eight administrations from prefilled syringes and 27 from ampoules were recorded. The mean times to prepare and administer the dose and dispose of the equipment were 67.6 seconds for a prefilled syringe and 128.5 seconds for an ampoule; the mean time saving per dose (95 per cent confidence intervals) was 60.9 (40.8, 80.9) seconds. The total cost per dose using a prefilled syringe was 104p; using an ampoule it was 113p. A generic cost model was created. The use of prefilled syringes saved approximately one minute of time and 9p (8 per cent) in cost per administration.     

Prefilled syringes for immunoglobulin G (IgG) replacement therapy: clinical experience from other disease settings

ABSTRACT

Introduction: Ready-to-use prefilled syringes for drug delivery are increasingly used across a broad spectrum of clinical specialties. For patients with primary immunodeficiencies manifesting as antibody deficiencies, immunoglobulin G (IgG) replacement therapy (IgRT) by subcutaneous administration is an established treatment modality. Expanding IgRT administration options through the introduction of prefilled syringes may further improve its utility.

Areas covered: Here, we collate experience with prefilled syringes from other clinical settings to inform on their practicality and suitability for IgRT. In addition to discussing drug characteristics such as stability, pharmacokinetics, and efficacy, we focus on treatment delivery, physician/patient experience, costs, and the importance of education for the use of prefilled syringes.

Expert opinion: Perceived benefits of prefilled syringes include accurate dosing, sterility, and reduced treatment time, while offering patients greater choice, convenience, and ease-of-use. Our review of clinical experience with prefilled syringes supports this consensus. Relatively few studies directly compare prefilled syringes with conventional administration, and robust studies of cost-effectiveness and health-related quality of life are needed on a drug-by-drug basis. Growth in the availability of prefilled syringes will continue, encouraged by the importance of patient choice and treatment convenience, toward the goal of individualized treatment regimens and improved quality of life.     

Comparison of seven methods of preparing and administering cefazolin sodium small-volume injections

The time and costs of preparing and administering cefazolin sodium small-volume injections using automated and manual systems were compared. Doses of cefazolin sodium 1 g were prepared in batches of 100 using each of seven methods, and preparation and administration times were recorded during five time trials. Personnel time and total material costs were determined. Bulk-vial reconstitution methods included manual piggyback, manual 24-hour piggyback, and manual syringe systems and one automated syringe infusion method (Bard programmable dispensing pump). Three prefilled container systems (Faspak flexible plastic bags, manufacturers' partial-fill glass bottles, and cefazolin sodium 1-g vials reconstituted using the ADS 100 Physio-Control peristaltic pump and administered via the IVAC CRIS system) were compared with each other and with the bulk reconstitution methods. Of the bulk-vial methods, total preparation process times were significantly shorter for the 24-hour piggyback system. Of the prefilled container systems, total preparation process time was significantly shorter for the Faspak system. Total daily administration process time was shortest for the IVAC CRIS system. Material costs per dose were lowest for the IVAC CRIS system and highest for the syringe pump systems (manual syringe and Bard syringe). Although lowest cost per dose was identified with the IVAC CRIS system, the 24-hour piggyback system was the system of choice on the basis of similar cost savings, its ability to manage primary fluids, and practicality of use at this institution.     

丙泊酚中/长链脂肪乳预充注射液与注射液的经济性评价

目的:评价丙泊酚中/长链脂肪乳预充注射液与注射液的经济性以及配置药师的满意度.方法:采用现场模拟试验法,由5名配置药师在静脉用药调配中心分别对2种注射液模拟手术室环境进行配置准备.比较2种注射液的配置时间,采用最小成本分析方法评价2种注射液配置的经济性,采用问卷调查方法调查配置药师的满意度,评分1～5分依次表示非常不满...     

The recombinant human chorionic gonadotropin prefilled pen: results of patient and nurse human factors usability testing

Objectives: The first prefilled pen for administration of recombinant human chorionic gonadotropin (r-hCG) has been developed. Usability testing was undertaken to evaluate the risk of dosing errors versus the existing r-hCG prefilled syringe, and assess function and handling of the pen.

Methods: Infertile women who were trying to conceive, and specialist nurses, were recruited in Germany. Usability goals were defined and categorized as critical or functional operational goals. Individual, non-interventional, standardized, usability tests (including ease-of-use assessment) were performed with patients and nurses. Cumulative test scores for critical operations were compared. Non-standardized qualitative analyses of nurse–patient training sessions were performed.

Results: The cumulative test score for the r-hCG prefilled pen was better than that of the existing prefilled syringe, so it was concluded that the overall risk of dosing errors was not higher with the pen. The ease of use of the pen was rated favorably by patients and nurses. Both user groups were confident that they could inject the correct dose using the pen.

Conclusions: The overall risk of dosing errors was not higher with the r-hCG prefilled pen than the existing prefilled syringe. The ease-of-use of the r-hCG prefilled pen was rated favorably by patients and nurses.     

Risk Mitigation of Plunger-Stopper Displacement Under Low Atmospheric Pressure by Establishing Design Space for Filling-Stoppering Process of Prefilled Syringes: A Design of Experiment (DoE) Approach

There is a concern that low atmospheric pressure typically encountered during shipment could result in plunger-stopper displacement in prefilled syringes impacting sterility and container closure integrity (CCI) of drug product.¹ In this work, following DoE principles we first investigated the impact of filling and stoppering operating parameters on creation of bubble height as performance parameters among others in nominal 1 mL and 2.25 mL Type I glass prefilled syringes (PFSs) with staked needle and rigid needle shield (RNS). Bubble height ranging from <2.0 mm to >15.0 mm were produced in syringes by filling water and vacuum stoppering at operating vacuum pressure ranging from 400 mbar to 950 mbar using a pilot scale filling-stoppering machine. We found that for a particular nominal fill volume in prefilled syringe, as the stoppering vacuum pressure increased, bubble height decreased resulting in plunger-stopper placed closer to the fill level. Subsequently, syringes with varying bubble size were exposed to reduced atmospheric pressure ranging from 628 Torr to 293 Torr bracketing the low pressure recommended by ASTM D4169 standard to qualify shipping containers for transportation of drug products. We found inverse linear correlation between bubble height and plunger-stopper displacement under low atmospheric pressure. However, plunger-stopper displacement increased exponentially as atmospheric pressure decreased. The results suggest that air bubble size in filled glass syringes should be minimized in order to mitigate sterility and container closure integrity (CCI) risk to drug product in prefilled syringes.     

Identification of an extraneous black particle in a glass syringe: extractables/leachables case study

An unexpected, black particle (～300 microns) was visually observed adhering to the interior shoulder of a prefilled glass syringe containing a biological drug product. The goal of this study was to determine the source, identity, and leachables of the black particle. The particle originated from a polymeric pin used during the syringe manufacturing process. Fourier transform infrared (FTIR) spectra comparison of the black particle and polymeric pin correlated to a database match of Nylon-MXD6 with glass fibers. Liquid chromatography/mass spectroscopy analyses identified Nylon-MXD6 and Nylon-6 photo-oxidized-related compounds in both the pin extract and syringe solution. The black particle originated from the pin and contained glass fibers, Nylon-MXD6, and Nylon-6. All nylon-related compounds were observed at <260 ng/mL (ppb) in the syringe solution. Syringes without black particles contained no detectable levels of nylon-related compounds, suggesting that routine contact between a pin and syringe barrel may not lead to syringe contamination or leachables originating from the pin. Abnormal heat exposure and/or extensive pin usage may have led to pin wear and tear.     

A cost benefit comparison of two antibiotic delivery systems in a children's hospital.

A comparative trial was undertaken in a 301 bed pediatric hospital to determine the feasibility and cost benefit of converting from a minibag intravenous admixture system to one using polypropylene syringes, prefilled with undiluted medication, for the administration of antibiotics. Technical and therapeutic problems unique to a pediatric hospital and the stability of antibiotics in polypropylene syringes were concurrent considerations. The cost of materials and total time involved were measured for each system for a one month period. It was concluded that the prefilled syringe system as a method of dispensing selected parenteral antibiotics, although requiring more time, is more cost effective than the minibag system.     

Effect of Various Silicone Oil And Tungsten Levels on the Stability of a Monoclonal Antibody in Nine Commercially Available Prefilled Syringes

Prefilled syringes are widely used as a primary container for therapeutic proteins because they are more convenient than glass vials. The stability of biologic molecules can be affected by different syringe materials and techniques, such as silicone oil levels and coating method, amount of tungsten remaining in the glass barrel after using a tungsten pin to create the needle hole, and end of the syringe, which can be Luer locked or pre-staked with a needle. We investigated the impact of these parameters by using a monoclonal antibody to collect the antibody's stability profile and the prefilled syringes’ functionality data. Silicone oil levels had no impact on aggregation levels, and particle counts were lowest for silicone oil–free syringes. Functionality performance was similar and did not change throughout all stability time points for all syringe configurations. The break-loose force for Ompi syringes was initially lower and increased over time to align with those of the other configurations, all of which remained well below 25 N. Tungsten contaminants and agitation stress from shipping studies did not impact quality attributes. This work can help guide the development of similar products in prefilled syringes to ensure selection of the primary container that provides adequate stability for the protein, as well as maintain the desired functionality features over the shelf life of the drug product.