提纯孕马血清促性激素的中试生产研究

孕马血清经偏磷酸，乙醇分级沉淀得比活为４０９ＩＵ／ｍｇ的粗品，回收率为４７．３％，粗品经离子交换层析得到比活为１４５５ＩＵ／ｍｇ的精品，回收率达９７．４％，再过柱层得比活为２４００ＩＵ／ｍｇ的产品。     

人绒毛膜促性腺激素的精制及去热原工艺

经两步骤从精品人绒毛膜促性腺激素（HCG）制得符合《中国药典》要求的HCG精品。并对两种去热原方法──DEAE纤维素柱层析法和磷酸盐吸附法进行了比较，层析法获得的HCG精品比活最高可达3800IU／mg，回收率最高可达30％；吸附法所获精品比活可达2200IU／mg，回收率则高达96％，后者操作简单、经济，更适合工业化生产。     

人尿胰蛋白酶抑制剂与激肽释放酶联产及纯化的研究

本文探讨了采用Polyerde-3吸附剂,从男性尿中提取HUTI-HUKN粗品,再依次经抑肽酶-琼脂糖4B亲和层析、胰蛋白酶-琼脂糖4B亲和层析,将HUTI和HUKN分离并纯化。每20升尿液得精品HUTI50mg,比活1,250u/mg;HUKN3mg,比活666u/mg。活性回收率分别为41％和50％。     

人超氧化物歧化酶的纯化及抗炎作用研究

粗品人超氧化物歧化酶经热变性，硫酸铝钾沉淀、离子交换层析及超滤处理后，得到比活＞１２０００Ｕ／ｍｇ蛋白质的精品，平均活力回收率５２．３％，比活为粗吕的２６．７倍；ｈＳＯＤ制剂的药效试验表明，无论肌肉注射或静脉注射给药途径，均有显著对抗巴豆油及角叉菜胶引起的炎产下及ＨＡＣ引起的毛细血管通透性增加的作用，剂量１００００Ｕ／ｋｇ－１６００００Ｕ／ｋｇ体重之间时，其作用与剂量变化无相关性。     

胰激肽释放酶的分离纯化

探讨了利用离子交换纤维素(DEAE-cellulose)从分离弹性酶后的母液中吸附分离胰激肽释放酶的较优化工艺。平均得量1.832 g/kg 胰脏,比活12.34 u/mg,回收率为65.4%。它还能提高粗品胰激肽释放酶的比活,回收率为81.0%。     

高效液相亲和层析介质的制备和对基因重组α-干扰素的纯化

以硅胶为基质，经表面改性和单克隆抗体固定化，制备了高效液相亲和层析介质。在改性反应中，以γ-缩甘油氧基丙基三甲氧基硅烷为改性剂，比较了水相法键合与有机相法键合的硅烷化率。用合成的α干扰素单克隆抗体高效液相亲和介质纯化由大肠杆菌表达的基因重组人α干扰素，层析过程的活性回收率为94％，纯化倍数为79倍，比活为7.94×106IU／mg。     

籽草SOD的分离纯化

从籽草中分离纯化的SOD比活为1855U／mg，纯化倍数约为100倍，总活力回收率22．6％，经SDS-PAGE测定，纯化的SOD纯度达电泳纯，该酶对氰化物和过氧化氢敏感，可证明其为Cu／Zn-SOD。     

人绒毛膜促性腺激素生产新工艺

采用 Polyerde 吸附柱层析,从孕尿起始一步制备500～1000 IU/mg 的 HCG 粗品,活性回收率为92～96%。     

由人尿促性腺激素分离纯化促卵泡成熟激素的方法研究

报道一种从促卵泡成熟激素（FSH）活性为23IU／mg的人尿促性腺激素（HMG）制品中分离纯化FSH活性大于60IU／mg的HMG制品的方法，其FSH活性回收率达到60％以上。     

大肠杆菌L—天门冬酰胺酶的提取和纯化

用蔗糖溶液提取菌体细胞周质中的天门冬酰胺酶，所获得的粗酶液经硫酸铵分级沉淀、DEAE-纤维柱层析和羟甲基纤维素柱层析纯化，获得了比活为220IU/mg，SDS-PAGE显示一条带的L-天门冬酰胺酶。     

人绒毛膜促性腺激素纯化工艺研究

经有机溶剂提取和ＤＥＡＥ－纤维素柱色谱分离，获得生物活性约３０００ＩＵ／ｍｇ的无热原ＨＣＧ精品，活性回收率达８０％以上。     

批式吸附法制备人凝血因子Ⅸ复合物

目的制备纯度较高,潜在血栓性小的凝血因子Ⅸ(FⅨ)复合物.方法以人新鲜冰冻血浆为原料,采用SD病毒灭活工艺,经国产DEAE-Sepharose Fast Flow胶批式吸附和Ca3(PO4)2吸附制备凝血因子Ⅸ复合物.结果两步的活性收率分别为(89.94±1.31)%(n=7)、(82.27±2.18)%(n=6),制品的FⅨ∶C比活为(16.28±2.80)IU/mg.FIX的量为(126.82±11.60)IU/瓶(200PE).结论本工艺实用性较高,可用于制备低成本,高质量的凝血因子Ⅸ复合物.     

Preparation of lyophilized heat-treated cryoprecipitates from a small pool of plasma obtained by apheresis

A method was developed for the batch-wise production of small-pool lyophilized heat-treated cryoprecipitates in a regional Blood Bank. Ten vials of final product were derived from twenty 600 g apheresis plasma donations. We found 384 IU of factor VIII per vial and a specific activity of 0.20 IU per mg total protein. Production recovery was 340 IU of factor VIII per kg plasma. The method was easy to perform and gave a product of good quality.     

155位Cys突变成Ser对IFN-ε纯化结果的影响

目的 比较重组人干扰素ε(recombinant human interferon-ε,rhIFN-ε)Cys155和rhIFN-εSet155两种蛋白质的回收率和抗病毒活性,以研究155位Cys突变成Ser对IFN-ε纯化和生物学活性的影响.方法 对rhIFN-εCys155和rhIFN-εSer155两种蛋白质分别进行纯化和抗病毒活性鉴定,并进行数据比对.结果 得到rhlFN-εCys155和rhlFN-ε Ser155两种活性蛋白,回收率分别为15.41%和29.18%,抗病毒活性分别为(1.293±0.268)×105IU/mg和(1.026±0.172)×105IU/mg.结论 两种蛋白质相比.突变样品回收率明显高于未突变样品,但氨基酸突变对rhlFN-ε的抗病毒活性没有明显影响.     

人凝血因子Ⅷ提取工艺优化研究

目的：优化血浆中人凝血因子Ⅷ提取工艺条件。方法以人血浆冷沉淀为原料,人凝血因子Ⅷ的比活性回收率作为评价指标,采用单因素试验,对铝胶的加量,铝胶吸附时的pH值、酸沉淀时的pH值等进行研究,优选提取工艺。结果加入冷沉淀重量12%的铝胶,并将pH值调节至7.1进行吸附,上清液中人凝血因子Ⅷ比活性可达9.50IU/mg,酸沉淀时将pH值调节至6.3,离心上清夜中人凝血因子Ⅷ比活性为11.50 IU/mg。经过以上两步处理,可将人凝血因子Ⅷ比活性提高近2倍。结论人凝血因子Ⅷ提取工艺优化研究工艺合理、可行,能有效达到纯化提取人凝血因子Ⅷ的效果。     

Clinical study on the dose-effect relationship of a nifuratel-nystatin combination in the treatment of vulvo-vaginal infections

OBJECTIVE: The dose-effect relationship of nifuratel (CAS 4936-47-4) + nystatin (CAS 1400-61-9, CAS 34786-70-4) (Macmiror Complex) in topical treatment of vulvo-vaginitis was studied. METHOD: Sixty patients with Trichomoniasis and/or Candidiasis were randomized to: 1) nifuratel 125 mg/nystatin 50000 IU, 2) nifuratel 250 mg/nystatin 100000 IU, 3) nifuratel 500 mg/nystatin 200000 IU. Undistinguishable ovules were intravaginally applied qd for 10 days. The dose-effect relationship was assessed by ANCOVA. RESULT: After 5 days the microbiological cure rate occurred in 10% of patients in the least dose, in 40% in the middle dose and in 85% in the highest dose group (P = 0.000). After 10 days of treatment, the microbiological cure rate increased to 45%, 84%, and 95%, respectively (P = 0.007). Clinical signs and symptoms gradually disappeared in a dose- and time-dependent manner. No relapse has been observed after 10 day-follow up on 46 patients. CONCLUSION: The results confirmed a linear relationship between nifuratel + nystatin dose and effect. The least effective dose was nifuratel 250 mg + nystatin 100,000 IU once daily for 5 days and the best dose in terms of risk/benefit ratio was nifuratel 500 mg + nystatin 200,000 IU once daily for 5 days.     

Cardioprotective effects of recombinant human extracellular-superoxide dismutase type C in rat isolated heart subjected to ischemia and reperfusion.

The cardioprotective effect of recombinant human extracellular-superoxide dismutase type C (rh-EC-SOD C) was studied in isolated perfused rat heart subjected to left coronary artery ligation for 30 or 60 min followed by 30-min reperfusion. A comparison was made with the effects of bovine CuZn-SOD. Reperfusion after 30-min coronary artery ligation was associated with a release of creatine kinase (CK) into the coronary effluent (71 +/- 5.2 IU/30 min), which was markedly reduced (39 +/- 5.5 IU/30 min) in hearts perfused with rh-EC-SOD C (28 mg/L). CuZn-SOD (4 or 20 mg/l) or a lower concentration of rh-EC-SOD C (5.6 mg/l) did not significantly attenuate CK outflow during reperfusion, however. In both vehicle- and SOD-treated hearts, the left ventricular developed pressure (LVDP) and the coronary flow recovered to 80-90% of baseline at the end of the reperfusion period. Increasing the ischemic period from 30 to 60 min caused a much more pronounced cardiac injury measured after 30-min reperfusion. In the hearts that received vehicle, recovery of LVDP (in percentage of baseline values) at the end of reperfusion was 58 +/- 2%, which was increased to 84 +/- 3 and 83 +/- 5% after treatment with rh-EC-SOD C (28 mg/L) and CuZn-SOD (20 mg/L), respectively. The corresponding values for recovery in coronary flow were 54 +/- 3% (vehicle), 69 +/- 4% (rh-EC-SOD C), and 74 +/- 3% (CuZn-SOD).(ABSTRACT TRUNCATED AT 250 WORDS)     

米非司酮联合5-氟脲嘧啶治疗异位妊娠72例临床分析

目的 探讨米非司酮(Ru486)联合5-氟脲嘧啶(5-Fu)治疗异位妊娠的疗效以及与血HCG的关系.方法 将72例异位妊娠患者随机分为两组:A组(5-FU Ru486联合组)即5-FU单次肌注30mg/m2后,空腹口服Ru486 50mg;B组(5-FU组)即单次肌注30mg/m2.定期监测血HCG至正常.结果 A组治愈率89.74%,血HCG＜6000IU/L,治愈率100%;B组治愈率78.79%,血HCG＜6000IU/L,治愈率85.71%,差异具有显著性意义(P＜0.01).A组联合治疗异位妊娠效果优于B组单独用药.结论 米非司酮联合5-Fu治疗异位妊娠效果优于单用5-Fu,成功率高,对于未生育的妇女避免了手术风险、减少了并发症,具有一定的临床意义.     

枯草杆菌溶栓酶的分离纯化研究

目的 :以枯草杆菌HL 986发酵液为原料 ,对枯草杆菌溶栓酶的分离纯化技术进行研究。方法 :采用磷酸钙吸附沉淀除去部分色素和杂蛋白 ,经超滤脱盐、CM 5 2离子交换分离、丙酮沉淀和SephadexG 75凝胶过滤处理 ,得到具有溶栓活性的酶。结果 :得到的溶栓酶在SDS PAGE上为单一谱带 ,其分子量约为 2 7kD ,比活为980 0U/mg,活性得率为 6 3.8%。结论 :以较高的得率获得了高纯度的枯草杆菌溶栓酶。