注射用芪红脉通配液除杂工艺研究

目的 以注射用芪红脉通为研究对象,确定制剂工艺超滤前最佳除杂技术。方法 考察冷藏、离心、活性炭吸附组合工艺对药液中杂质及有关物质的去除情况。以黄芪总皂苷、黄芪甲苷、羟基红花黄色素A的质量浓度、固含物减少率、蛋白质质量浓度、有关物质检查结果等为评价指标,确定除杂方法的可行性并优化工艺参数。结果 最佳工艺参数为冷藏24 h,离心时间15 min、转速5 000 r/min,活性炭用量0.3%、温度40 ℃、吸附时间30 min、原药液pH值。结论 冷藏、离心和活性炭吸附组合工艺除杂效果显著,可有效去除树脂、蛋白质等杂质。     

ZTC 1＋1用于养阴清肺糖浆水提液的絮凝工艺研究

目的 优化养阴清肺糖浆的生产工艺,更好地保留有效成分,提高药液的澄清度。方法 采用天然高分子絮凝剂ZTC 1＋1对养阴清肺糖浆原药水提液进行絮凝处理,以有效成分甘草酸保留率和药液浊度为衡量指标,考察絮凝剂用量、絮凝温度、搅拌速度、搅拌时间对絮凝效果的影响,并将絮凝后的药液离心处理,以确定最佳工艺条件。结果 最佳絮凝提纯工艺条件为药液温度30 ℃,ZTC 1＋1用量0.6 g/L,快搅速度450 r/min,快搅时间2 min,慢搅速度50 r/min,慢搅时间10 min,絮凝后的药液再在转速3 000 r/min下离心20 min,此时甘草酸保留率为84%,药液浊度只有1.3 NTU。结论 ZTC 1＋1用于养阴清肺糖浆原药水提液的絮凝提纯效果明显优于醇沉法,絮凝法可以替代醇沉法用于养阴清肺糖浆水提液的提纯。     

壳聚糖对小儿咳喘灵原药提取液絮凝除杂效果研究

目的 探索小儿咳喘灵原药提取液高效絮凝除杂工艺,更好地去除杂质,保留有效成分,提高药液的澄清度及其稳定性。方法 采用壳聚糖对小儿咳喘灵口服液原药提取液进行絮凝处理,以有效成分绿原酸保留率、鞣质和蛋白质的去除率及药液浊度作为主要衡量指标,考察絮凝剂用量、絮凝温度、搅拌速度及搅拌时间对絮凝效果的影响,以期得到适宜的絮凝工艺条件。结果 确定了壳聚糖絮凝小儿咳喘灵口服液原药提取液的最佳絮凝工艺为药液温度30 ℃,加入壳聚糖0.75 g/L,先在搅拌桨叶片顶端线速度为1.31 m/s的条件下快速搅拌120 s,再在0.26 m/s的速度下搅拌15 min,絮凝后的药液在分离因数为1 430条件下离心20 min,此时绿原酸的保留率为94.6%,鞣质和蛋白质的去除率分别为44.7%和51.6%,药液浊度为1.1 NTU。药液静置存放90 d后浊度仅为3.5 NTU,稳定性突出。与醇沉法相比,壳聚糖对于小儿咳喘灵原药提取液的絮凝除杂效果良好,有效成分绿原酸及多糖的保留率分别提高了6.3%和25.8%,鞣质去除率提高21.6%,药液的浊度仅是醇沉浊度的1/4,放置3个月药液浊度的上升幅度仅为醇沉法的1/5。结论 絮凝法可以用于小儿咳喘灵口服液原药液的净化除杂工艺。     

丹参水提液的纯化工艺研究

目的 优选丹参水提液纯化工艺。方法 以丹参提取液的浊度、鞣质以及有效成分的量为指标,优选两种絮凝澄清剂的用量和絮凝搅拌速度,筛选出较佳参数;对比研究醇水沉淀、絮凝结合乙醇沉淀、絮凝结合膜过滤3种纯化方法。结果 使用壳聚糖进行絮凝澄清处理后的丹参水提液上清液浊度低于用ZTC1+1Ⅱ型絮凝剂处理后的浊度,并能够更好地减轻膜污染程度;壳聚糖结合膜过滤法对丹参水提液的有效成分保留率较高,收膏率相对较高,浊度和鞣质含量无显著差异。结论 壳聚糖作为丹参水提液絮凝澄剂效果优于ZTC1+1Ⅱ型絮凝剂,壳聚糖结合膜过滤法纯化丹参水提液的综合评价指标优于其他两种方法。     

栀子环烯醚萜苷的大孔吸附树脂纯化工艺研究

目的 研究大孔吸附树脂纯化栀子环烯醚萜苷类成分的工艺条件及参数。方法 采用UV法和HPLC法分别测定栀子总环烯醚萜苷和栀子苷的量;采用静态吸附和动态吸附考察大孔吸附树脂的吸附、解吸性能和纯化效果。结果 综合考虑生产成本及纯化效果,D-101大孔吸附树脂纯化效果较好,最佳工艺条件：柱高径比3∶1,上样液质量浓度为1.0 g/mL、吸附体积流量为0.5 BV/h、树脂吸附量为生药2.5 g/g、洗脱溶媒为50%乙醇、洗脱体积流量为2 BV/h,洗脱溶媒用量2 BV。结论 D-101大孔吸附树脂对栀子环烯醚萜苷纯化效果较好,工艺稳定可行,可用于工业化生产。     

栀子苷经鼻给药醇质体喷雾剂的制备及其体外鼻黏膜渗透性研究

目的 研究栀子苷经鼻给药醇质体喷雾剂的最佳制备工艺,并考察其体外鼻黏膜渗透性规律和该制剂的鼻黏膜纤毛毒性。方法 采用注入法制备栀子苷醇质体,以包封率为评价指标,应用星点设计-效应面法对栀子苷醇质体制备过程中有关影响因素及工艺参数进行优化;采用透射电镜和光子相关光谱仪考察其药剂学性质;以离体猪鼻腔黏膜为模型,考察栀子苷醇质体喷雾剂的体外透黏膜给药规律,并与其脂质体及水溶液进行比较;以在体蟾蜍口腔上腭纤毛在药物溶液作用下持续摆动的时间评价制剂的鼻黏膜纤毛毒性。结果 最优处方条件下制备的栀子苷醇质体粒径为（173.40±71.02）nm,Zeta电位为（?42.50±8.27）mV,包封率为（65.80±2.53）%,载药量为（5.25±0.15）%。栀子苷醇质体300 min经鼻黏膜单位面积渗透量为23.39 μg/cm²,是其脂质体的2.17倍、水溶液的11.03倍。此外,该制剂基本无鼻黏膜纤毛毒性。结论 优选得到的栀子苷醇质体处方和制备工艺合理,能够显著提高栀子苷的鼻黏膜渗透性,可用于鼻腔给药。     

清咽利肺散医院制剂的关键工艺研究

目的 摸索中药医院制剂"清咽利肺散"处方水提液的纳滤浓缩工艺及干燥方法.方法 采用HPLC测定黄芩苷经过纳滤浓缩后的保留率,以黄芩苷的保留率和膜通量为指标,通过单因素试验分析纳滤操作压力、吸附特征等因素对水提液浓缩工艺的影响.比较纳滤浓缩前后提取液HPLC图谱的一致性,并进一步比较两者的喷雾干燥效果.结果 黄芩苷的保留率未受压力、浓缩倍数的影响,纳滤浓缩前后药液的HPLC图谱基本一致;提取液经过纳滤浓缩再喷雾干燥所得粉末更稳定.结论 纳滤适用于浓缩清咽利肺处方的水煎提取液,纳滤浓缩液经过喷雾干燥后制成的散剂更稳定.     

活血通络注射液超滤工艺的膜污染及清洗研究

目的 考察活血通络提取液在超滤时不同药液性质对超滤膜污染程度的影响及不同清洗方法对恢复被污染超滤膜纯水通量的能力。方法 采用正交试验考察超滤时药液温度、超滤前药液质量浓度、药液pH值对膜污染程度的影响;考察不同膜清洗方法（超声、0.1 mol/L NaOH清洗、0.1 mol/L NaClO清洗、0.1 mol/L HCl清洗）对膜通量恢复情况的影响。结果 药液在稀释1倍且保持温度60 ℃,pH 2时膜污染程度较小,且指标成分苦杏仁苷转移率高。膜清洗采用0.1 mol/L NaOH、0.1 mol/L NaClO循环后1 h,浸泡2 h再循环清洗1 h对膜纯水通量恢复作用最好,0.1 mol/L HCl能恢复至80%左右,超声无明显恢复作用。结论 确定药液超滤方法和膜清洗方法能有效地提高活血通络注射液生产效率。     

参松养心胶囊水提液陶瓷膜除杂工艺研究

目的 考察不同规格陶瓷膜对中药大品种参松养心胶囊水提液除杂的效果,并优化工艺参数。方法 以参松养心胶囊水提液为研究对象,比较3种不同孔径的陶瓷膜在不同条件下,对膜通量衰减、药液有效成分保留率等方面的影响。结果 滤过孔径为100 nm的陶瓷膜对参松养心胶囊水提液滤过效果较好,膜通量及芍药苷转移率均较高,最佳滤过条件为进液压力0.15～0.22 MPa,滤过温度20 ℃。结论 陶瓷膜滤过技术可较好地对参松养心胶囊水提液进行除杂,该技术可进一步推广到其他中药水提液的除杂工艺中。     

注射用芪红脉通微滤液的超滤工艺适用性研究

目的 以注射用芪红脉通微滤后药液为研究对象,考察4种不同材质的中空纤维超滤膜对注射用芪红脉通药液体系的适用性。方法 分别选取截留相对分子质量为100 000的聚砜、聚醚砜、聚丙烯、混纺复合4种材质的超滤膜进行超滤,测定不同膜材质超滤过程的膜通量,指标成分黄芪总皂苷、黄芪甲苷、羟基红花黄色素A（hydroxy safflower yellow A,HSYA）透过率,固含物减少率,蛋白质减少率,有关物质及热原检查,筛选适宜本产品的超滤膜。结果 相同截留相对分子质量的4种不同材质超滤膜对同一药液体系的适用性存在差异：聚丙烯、聚醚砜和混纺复合材质的膜纯水通量恢复率均较高,而聚砜材质的膜通量和膜纯水通量恢复率较低;聚丙烯与聚醚砜材质的指标成分透过率较高,聚砜与混纺复合材质的固含物与蛋白质去除率较高;对于本产品,截留相对分子质量为100 000超滤膜可有效去除热原。结论 聚丙烯-100000超滤膜既能有效去除固含物与高分子物质,又能保留有效成分,适用于注射用芪红脉通的精制。     

Value of D-Dimers in patients with acute aortic dissection

Objective: To evaluatel the value of D-dimers in patients with acute aortic dissection (AAD). Methods: This study consisted of 16 patients with AAD and 27 non-AAD patients. Serum D-dimets were measured by Sta-Liatest D-DI immunoturbidimetric assay. Results: D-dimer level was higher (P ＜ 0.001) in patients with AAD(7.91 ± 5.52 μg/ml) than that in non- AAD group(1.57±1.24 μg/ml). D-dimer was positive (＞0.4 μg/ml) in all patients with AAD and in 10 control group patients (37%). Among patients with acute AAD, D-dimers tended to be higher in Stanford A than in Stanford B (8.67 ± 4.31 μg/ml vs. 3.24±1.27 μg/ml, P ＜0.01). D-dimer values tended to be higher in more extended disease(3.84 ± 1.65 μg/ml, 8.57 ± 3.58 μg/ml and 11.87 ± 5.69 μg/ml in thoracic aorta, thoracic and abdominal aorta, thoracic and abdominal aorta and iliacal arteries, respectively, P ＜ 0.05 for both 8.57 ± 3.58 and 11.87 ± 5.69 vs. 3.84 ± 1.65 ). Including the control group into the analysis, we found a sensitivity of 100%, a negative predictive value of 100%, and a specificity of 66% and a positive predictive value of 64% for D-dimer in diagnosis of AAD in our patients with suspected AAD. Conclusion: D-dimer was elevated in patients with AAD. A negative D-dimer test result could be useful in excluding AAD.     

Research of combined liver-kidney transplantation model in rats

Objective： To set up a simple and reliable rat model of combined liver-kidney transplantation. Methods： SD rats served as both donors and recipients. 4℃ sodium lactate Ringer＇s was infused from portal veins to donated livers,and from abdominal aorta to donated kidneys, respectively. Anastomosis of the portal vein and the inferior vena cava （IVC） inferior to the right kidney between the graft and the recipient was performed by a double cuff method, then the superior hepatic vena cava with suture. A patch of donated renal artery was anastomosed to the recipient abdominal aorta. The urethra and bile duct were reconstructed with a simple inside bracket. Results： Among 65 cases of combined liver-kidney transplantation, the success rate in the late 40 cases was 77.5%. The function of the grafted liver and kidney remained normal. Conclusion： This rat model of combined liver-kidney transplantation can be established in common laboratory conditions with high success rate and meet the needs of renal transplantation experiment.     

BLOOD PRESSURE CHANGE WITH AGE IN SALT-SENSITIVE TEENAGERS

Objective To observe blood pressure change with age in salt-sensitive teenagers whose salt sensitivity were determined by repeated testing.Methods Salt sensitivity was determined through intravenous infusion of normal saline combined with volume-depletion by oral diuretic furosemide in 55 teenagers. After five years, salt sensitivity was re-examined and subject blood pressure was followed up. Blood pressure changes in salt-sensitive teenagers were compared to that of non-salt sensitive teenagers over five years.Results After 5 years, the repetition rate of salt sensitivity determined by intravenous saline loading is 92.7%. In teenagers with salt sensitivity on the baseline, both the systolic blood pressure increments and increment rates were much higher than non-salt sensitive teenagers (12.7±12.1 mmHg vs. 2.8±5.2 mmHg, P＜ 0.01; 12.2%± 12.0% vs. 2.5% ±4.4%, P＜ 0.001,respectively). There was a similar trend for diastolic blood pressure (8.4 ± 6.4 mmHg vs. 3.7 ± 6.4 mmHg, P = 0.052; 13.2% ±10.6 % vs. 6.8%± 10.1%, P = 0.053, respectively).Conclusions Salt sensitivity determined by intravenous saline loading showed good reproducibility. Blood pressure increments with age were much higher in salt-sensitive teenagers than non-salt sensitive teenagers, especially in terms of systolic blood pressure.     

安心颗粒对急诊经皮冠状动脉介入术后生活质量影响的研究

目的：评价使用安心颗粒对急诊经皮冠状动脉介入术（PPCI）术后生活质量的影响.方法：将160例接受PPCI的急性ST段抬高型心肌梗死患者随机分为安心颗粒组（术前顿服安心颗粒8.8g,术后安心颗粒4.4 g/次,每日2次）和对照组（仅接受基础药物治疗）.所有患者均服用阿司匹林、氯吡格雷和阿托伐他汀.分别在入院时、出院前1d、出院后180 d时,应用心肌梗死多维度量表（MIDAS）、中文版SF-36评价量表对患者生活质量评分.并观察术后30 d以内的出血并发症、血小板减少症发生情况.结果：入院时和出院前1d,两组患者的心肌梗死MIDAS、SF-36量表评分比较无差异（P＞0.05）;出院后180 d时,与对照组比较,安心颗粒组MIDAS、SF-36评分明显减低（P＜0.05）;组内与入院时比较,两组出院前1d、出院后180 d时,MIDAS、SF-36评分均降低（P＜0.05）.两组患者在随访期间均无大量出血、少量出血、重度和极重度血小板减少症发生,安心颗粒组有4例、对照组有7例发生不明显出血（P＞0.05）.两组发生轻度血小板减少症的患者数比较无差异（P＞0.05）.结论：PPCI使用安心颗粒,能改善急性ST段抬高型心肌梗死患者的生活质量,且不增加出血风险.     

The comparative studies of the influences of Urapidil and Nicardipine on sino-atrial node function, atrio-ventricular node function and hemodynamics

Objective:To investigate the influences of urapidil and nicardipine on rabbit sinus function,atrio-ventricular node function and hemodynamics.Methods:Thirty-two Angora's rabbits were selected and randomly divided into four groups.U1 group:urapidil 0.25 mg/kg;U2 group:urapidil 0.5 mg/kg;N1 group:nicardipine 10 μg/kg;N2 group:nicardipine 20 μg/kg.All these medicine were administrated within 30 seconds.Measurements were taken before and after the administration of urapidil or nicardipine for the following data:mean blood pressure(MAP),heart rate(HR),sino-atrial conduction time(SACT),maximal sinoatrial recovery time(SNRTmax)corrected sinus node recovery time(CSNRT),index of sinus node recovery time(SNRTI),Wenckebach A-V conduction frequency (WB),and P-R interval.Results:Significant MAP and HR changes were identified in all of the four groups before and after administration of both urapidil and nicardipine.No significant changes could be found in the rest of the parameters.Intergroup analysis showed that SACT and CSNRT of N1 and N2 groups were shorter than those of the U2 group(P＜0.01);the MAP decreased(P＜0.01)and the HR increased drastically(P＜0.01).Conclusions:Neither urapidil(0.25 mg/kg,0.5 mg/kg)nor nicardipine(10μg/kg,20μg/kg)has any significant influence on rabbit sinus function or rabbit atrio-ventricular node function.Nicardipine could be a better choice than urapidil for parafunctional sinus node patients.     

Expression of OPGmRNA and ODFmRNA in the patients of hip fracture due to osteoporosis

Objective：To investigate the gene expression of osteoprotegerin（OPG） and osteoclast differentiation factor（ODF） in the bone tissue of patients with hip fracture due to osteoporosis. Methods：OPGmRNA and ODFmRNA in the bone tissue in 50 cases of osteoporosis sufferers（over 50 years old） with hip fracture（Observer Group） and 30 cases of hip facture sufferers with no osteoporosis（Control group） were analyzed with the Semi-Quantitative RT-PCR method. Results：The mRNA expressed of ODF, OPG were both high in the patients with hip fracture. In the control group, the expression of OPG mRNA was observed, while the expression of ODF mRNA was very slight. Conclusion：Aged patients contained all signals including OPG, ODF that are essential for inducing osteoclastogenesis and promoting bone resorption.     

The clinicopathological and immuohistochemical analysis of solid-pseudopapillary tumor of the pancreas： report of 9 cases

Objective：To investigate the clinical features, pathological characteristics and immunophenotype of solid-pseudopapillary tumor of the pancreas（SPTP）. Methods：Nine surgically treated cases of SPTP were retrospectively reviewed. Hematoxylin and Eosin（HE） staining and immunohistochemical staining were used to analyze all cases, and the general clinical data was collected. Results：Six patients were asymptomatic except for a palpable mass. Two patients complained of vague-epigastric pain. One patient appeared jaundice. The tumor was encapsulated and solid tissues alternately with cystic tissues. Histologically, the histological structure of solid portion was pseudopapillary with a fibrovascular core. Tumor cells were uniform and medium-sized which were arranged in sheets ets or nests or pseudopapillary patterns. Immunohistochemical studies demonstrated that SPTP proved positive in vimentin（9/9 cases）, AAT（9/9 cases）, NSE（9/9 cases）, ACT（7/9 cases）, CK20（2/9 cases）, CgA（1/9 cases）, S-100（3/gcases）, PR（4/gcases）, Syn（3/9 cases） and CD56（5/9cases）, negative in CEA and ER. Conclusion：SPTP is a tumor predominantly occurring in young women frequently without special symptoms. This tumor has various characteristical histological patterns with different immunophenotype.     

Dynamic Changes in Serum Estradiol and Progesterone levels in Patients of Premenstrual Syndrome with Adverse Flow of Liver-qi

Objective:To probe into the influence of changes of ovarian hormones on the pathogenesis of the specific sub-type premenstrual syndrome(PMS)and reveal partial microcosmic mechanisms of adverse flow of liver-qi.Methods:Estradiol(E2)and progesterone(P)levels in serum were determined at different phases of menstrual cycle by radioimmunoassay.Results:In the group of PMS with adverse flow of liver-qi.the secretive peak value Of E2 and P at the follicular phase significantly decreased,and the secretive peak value at the luteal phase did not come into being.Conclusions:Low E2 and P secretive peak at the follicular phase and absence of secretive peak at the luteal phase is one of the microcosmic mechanisms of PMS with adverse flow of liver-qi.One of the pathophysiologic mechanisms of specific sub-type PMS is probably the continuous low level of E2and P.     

Real-time Three-dimensional Echocardiography in Assessment of Left Ventricular and Right Ventricular Volumes

Real-time three-dimensional echocardiography (RT3DE)is a new ultrasound technique that enables dynamic threedimensional visualization and quantification of the heart in real time. Investigation of feasibility and methodology of RT3DE in determining left ventricular (LV) and right ventricular (RV) volumes, RT3DE was performed in 35 normal adults using Philips SONOS 7500 system with a 2-4 MHz matrix array transducer. The 60°×60° "pyramid" volume database was obtained and analyzed on a TomTec echo workstation. Both LV and RV volumes were calculated with four 3DE methods (i.e. apical 2, 4, 8, and 16-plane) through manually tracing ventricular endocardial borders in end diastole and end systole. Stroke volumes were then calculated. LV volume was also measured by 2DE Simpson's rule using GE VIVID 7 ultrasound machine.     

SCREENING FOR A 21-CHROMOSOME ABNORMALITY IN PREIMPLANTED EMBRYOS OF ELDERLY WOMEN

Increasing maternal age is the only etiological factor unequivocally linked to Down's syndrome in humans. The occurrence rate of newborns with Down's syndrome is about 1/220 in women over 35 years old. However, the occurrence rate in embryos fertilized in vitro, of the elder woman is unclear. Using FISH we screened the number of chromosome 21 in preimplanted embryos of 5 elderly women (average age, 38.4 years) to study the feasibility and necessity of screening trisomy 21 in embryos in patients over 35 years old at the in vitro fertilization (IVF) center.