基于质量源于设计理念的丹参浓缩膏石硫工艺优化研究

目的基于质量源于设计理念优化了丹参川芎嗪注射液前处理过程中丹参浓缩膏的石硫工艺。方法使用鱼刺图法对丹参浓缩膏石硫工艺涉及的各个参数进行了初步风险评估,筛选出了9个潜在关键工艺参数(critical process parameter,CPP),即石灰乳质量分数、加石灰乳速度、搅拌速度、加石灰乳后搅拌时间、硫酸质量分数、加酸速度、加酸后搅拌时间、静置时间和静置温度。采用Plackett-Burman(PB)实验设计法对9个潜在CPP进行进一步筛选,确定了石灰乳质量分数、加石灰乳后搅拌时间、加酸后搅拌时间和静置时间为石硫工艺的CPP。采用中心复合实验设计法建立CPP和关键质量属性之间的偏最小二乘回归模型,根据石硫上清液中各指标需要达到的水平,通过计算获得基于概率的设计空间。结果推荐的石硫工艺操作空间为石灰乳质量分数12.0%～13.0%,加石灰乳后搅拌时间40～50 min,加酸后搅拌时间30～35 min,静置时间16～20 h。结论在设计空间内进行操作有助于提高石硫工艺中间体质量一致性,本研究对实际工业生产具有一定参考价值。     

Plackett-Burman设计联用星点设计-响应面法优选大青叶中靛玉红的提取工艺

目的运用Plackett-Burman实验设计联用星点设计-响应面法(CCD-RSM)筛选超声-微波协同提取大青叶中靛玉红的提取工艺。方法运用Plackett-Burman实验设计筛选主要影响因素,采用CCD-RSM优选靛玉红的提取工艺。以乙醇体积分数、料液比、提取时间为自变量,靛玉红提取量为因变量,通过对自变量与因变量的完全2次响应曲面的回归拟合,利用三维曲面图直观分析大青叶中靛玉红提取最佳工艺,并进行预测分析。结果靛玉红的最佳提取工艺为乙醇体积分数为62%,液料比为26,提取时间为9 min。在此最佳条件下,大青叶中靛玉红提取量的最大估计值为4.37 mg/g,实验结果与模型预测值相符。结论利用Plackett-Burman实验设计联用CCD-RSM确定了大青叶中靛玉红的提取工艺,该方法简便,精度更高、重现性好、预测性强。     

可长时间缓释骨形态发生蛋白2的聚己内酯复合支架的制备及应用

目的 制备一种可长时间缓释骨形态发生蛋2(BMP-2)的聚己内酯(PCL)复合支架,并通过检测其对人源骨髓间充质于细胞(BMSC)成骨分化的影响探讨其在骨组织工程中的应用.方法 将磷脂(PL)和BMP-2混合形成的BMP-2/PL混合物(B/P)分散在二氯甲烷中,与PCL混合后,采用相分离法制备负载BMP-2的三维PCL-B/P复合支架和PCL-B传统支架,通过酶联免疫吸附试验(ELISA)检测两种支架的BMP-2缓释效果.将BMSC种植在PCL-B传统支架和PCL-B/P复合支架中,分别采用CCK-8法和实时定量PCR(qPCR)检测两种支架上BMSC的增殖和成骨分化能力.结果 与PCL-B传统支架对比,PCL-B/P复合支架对BMP-2缓释效果更佳,缓释时间更长,可达22 d.在BMSC培养的第7、14和21天,PCL-B/P复合支架上BMSC的增殖能力均优于PCL-B传统支架(P＜0.05),且PCL-B/P复合支架上BMSC中碱性磷酸酶和Ⅰ型胶原蛋白、骨钙、骨桥蛋白3种成骨基因mRNA的表达均高于PCL-B传统支架(P＜0.05,P＜0.01).结论 成功地制备出一种可长时间缓释BMP-2的高分子三维PCL-B/P复合支架,其较PCL-B传统支架能更好地诱导BMSC的增殖和成骨分化.     

Living Donor Uterus Transplant and Surrogacy: Ethical Analysis According to the Principle of Equipoise

The uterus is the most recent addition to the list of organs that can be successfully transplanted in humans. This article analyzes living donor uterus transplantation according to the ethical principle of equipoise. A comparison is made between living donor uterus transplantation and gestational surrogate motherhood. Both are solutions to absolute uterine infertility that allow the transfer of genetic material from intended parents to a child. The analysis concludes that living donor uterus transplantation does not violate the ethical principle of equipoise and should be considered an ethically acceptable solution to absolute uterine infertility.     

Living Donor Uterus Transplantation: A Single Center's Observations and Lessons Learned From Early Setbacks to Technical Success

Uterus transplantation is a vascularized composite allograft transplantation. It allows women who do not have a uterus to become pregnant and deliver a baby. In this paper, we analyze the first five cases of living donor uterus transplantation performed in the United States. The first three recipients lost their uterus grafts at days 14, 12, and 6, respectively, after transplant. Vascular complications, related to both inflow and outflow problems, were identified as the primary reason for the graft losses. Two recipients, at 6 and 3 mo, respectively, after transplant, have functioning grafts with regular menstrual cycles. Ultimate success will be claimed only after a live birth. This paper is an in‐depth analysis of evaluation, surgical technique, and follow‐up of these five living donor uterus transplants. The lessons learned were instrumental in allowing us to evolve from failure to technical and functional success. We aim to share our conclusions and build on knowledge in the evolving field of uterus transplantation.     

Penile transplantation: an emerging option for genitourinary reconstruction

Penile transplantation is an emerging option for patients with severe genital defects not amenable to traditional reconstructive options. In this article, we discuss the burgeoning problem of severe male genitourinary trauma in the military, the limitations of traditional reconstructive options in addressing these problems, and the potential for penile transplantation to provide improved outcomes. We also review the preclinical research and limited worldwide experience with penile transplantation to date, including lessons learned, and discuss the many important technical, logistical, and ethical considerations pertaining to penile transplantation that must be addressed to maximize the likelihood of successful implementation.     

Patellar Cut and Composite Thickness: The Influence on Postoperative Motion and Complications in Total Knee Arthroplasty

Background

Little data exist on the influence of patellar thickness on postoperative motion or complications after total knee arthroplasty (TKA). This study addresses the following questions: Is postoperative motion influenced by change in composite patellar thickness? Is change in patellar thickness associated with more complications? And do more complications occur in the knees with a patellar bone remnant (<12 mm) and a native patellar thickness <18 mm?

星点设计-效应面法优化细叶远志皂苷自微乳释药系统

目的 采用星点设计-效应面法优化细叶远志皂苷自微乳处方.方法 配伍试验、绘制伪三元相图进行处方筛选,以溶解度、粒径及乳化时间为指标,星点设计-效应面法优化处方.结果 细叶远志皂苷自微乳的处方配比为油酸乙酯12.93%,RH40 56.30%,1,2-丙二醇30.77%.结论 此方法的预测性良好,适用于细叶远志皂苷自微乳的处方优化.     

星点设计-效应面法优化芹菜籽挥发油羟丙基-β-环糊精的包合工艺

[目的]优化芹菜籽挥发油-羟丙基-β-环糊精包合物的包合工艺,并对包合物进行表征及评价。[方法]采用冷冻干燥法包合芹菜籽挥发油,以丁苯酞的包合率、载药量为评价指标,计算综合评分OD值。对包合温度、包合时间和芹菜籽挥发油与羟丙基-β-环糊精的比例进行单因素考察,并设计三因素五水平的星点实验。对实验结果进行多元线性、二项式及三项式拟合,采用效应面法筛选出的最佳包合工艺进行验证实验。采用高效液相色谱法（HPLC）测定包合物中丁苯酞的含量,采用紫外扫描法（UV）、差示扫描量热法（DSC）对芹菜籽挥发油-羟丙基-β-环糊精包合物进行表征。[结果]芹菜籽挥发油包合物的最优制备工艺为：芹菜籽挥发油：羟丙基-β-环糊精比例2：25、包合温度为44.5℃、包合时间167 min。此包合工艺制备的挥发油包合物包合率为78.95%,包合物中丁苯酞质量分数为2.982 mg/g。表征结果显示芹菜籽挥发油被羟丙基-β-环糊精成功包合。[结论]星点设计-效应面法适用于芹菜籽挥发油-羟丙基-β-环糊精的包合工艺优化,此方法建立的数学模型具有良好的预测性。     

不同复合树脂对牙体组织固化深度及黏结强度的影响

目的:探讨不同复合树脂对牙体的固化深度和黏结度的影响,为临床选择合适的树脂修复牙体提供依据.方法:选取离体磨牙90颗,随机分成3组,分别用Esthet-X、Charisma和Z3503种复合树脂修补,每组再次随机分2组分别用卤素灯、LED光固化灯固化,使用Single Bond黏结剂黏结,测量固化深度及黏结强度.结果:3种复合树脂的固化深度差异有统计学意义(P<0.01).Esthet-X复合树脂和Charisma复合树脂的卤素光固化灯及LED光固化灯固化深度均高于Z350(P<0.01).3种复合树脂LED光固化灯固化深度好于卤素灯(P<0.01).3种复合树脂的黏结强度差异有统计学意义(P<0.01),黏结强度依次为Esthet-X>Charisma>Z350(P<0.05).结论:3种复合树脂对牙体的固化深度不同,Esthet-X、Charisma复合树脂固化深度好于传统的Z350树脂,LED光固化灯固化深度好于卤素灯.使用同种黏结剂,Esthet-X复合树脂黏结强度最好,Charisma复合树脂次之,Z350最差.