体内和体外两种方法制备甲型副伤寒特异性转移因子

目的 比较体内、体外两种方法制备的甲删副伤寒特异性转移因子的理化性质及特异免疫活性.方法 此采用体内、体外两种方法制备甲型副伤寒特异性转移因子,检测其理化性质及以攻击试验测定特异免疫活性.结果 两种方法制备的甲型剐伤寒特异性转移因子理化性质及特异免疫活性无统计学差异,均符合中国药典生物制品标准.结论 定制备的甲型副伤寒特异性转移因子具有抗原特异性,能够转移针对甲型副伤寒沙门菌的特异免疫效庇.体外法是制备特异转移因子的一种更为简便、经济、有效的方法.     

猪脾乙肝特异性转移因子的研制

探索猪脾乙肝特异性转移因子（ＰＳＨＢＶ－ＴＦ）的制备方法,为临床提供合格的ＰＳＨＢＶ－ＴＦ制品。方法：用乙肝疫苗辅以佐剂对猪进行全程免疫,然后从猪脾中提制ＰＳＨＢＶ－ＴＦ;采用小鼠皮肤试验检测制品的特异性活性,并按卫生部规程要求对制品进行全检。结果：ＰＳＨＢＶ－ＴＦ具有抗乙肝特异性活性,即能转移针对乙肝病毒的特异性细胞免疫反应; ３批制品所有项目符合规程要求。结论：本法可制备出合格的 ＰＳＨＢＶ－ＴＦ制品,且适合于大规模化生产。     

体外免疫法制备结核特异性转移因子

以 PPD为抗原 ,猪脾细胞为效应细胞 ,经体外免疫后收集应答细胞 ,制备结核特异性转移因子。结果显示 ,体外法制备的结核特异性转移因子的主要免疫学指标 (皮内试验及白细胞粘附抑制试验 )与体内法制备的十分相近 ,为结核特异性转移因子的生产提供了新的途径。     

抗乙肝特异胎盘因子的制备

目的探索制备抗乙肝特异胎盘因子的方法。方法用乙肝疫苗作为抗原 ,体外免疫健康产妇胎盘白细胞 ,然后从白细胞中提取抗乙肝特异胎盘因子 ,采用小鼠皮肤试验检测制品的特异性活性。结果体外免疫法制备的抗乙肝特异胎盘因子能转移针对乙肝病毒的特异性细胞免疫反应。结论此法可制备出对乙型肝炎病毒具有特异性活性的免疫调节剂     

羊胎盘提取液的活性检测实验研究

研究羊胎盘提取液(sheep placenta extract,SPE)的免疫活性。对活性测定脱E受体法中2个影响玫瑰花环形成的重要因素—脱E受体和受体重新合成时间进行了比较和筛选,并对SPE剂量效应及由不同保存期羊胎盘制备的SPE免疫活性进行比较研究。结果在E玫瑰花环实验中当45℃水浴脱E受体时间为45 min,37℃水浴E受体重新合成时间为90 min时,玫瑰花环形成率增加值最大。花环形成率与SPE刺激剂量存在非线性关系,浓度为0.125~1 mg/ml的SPE花环形成效果较好。保存1年的羊胎盘制备的SPE免疫活性明显低于新鲜羊胎盘制备的SPE免疫活性(P<0.01)。新鲜羊胎盘制备的SPE可作为免疫调节类生物药品研发,其活性检测应选择一定的剂量范围。     

抗乙肝转移因子口服液的研制

将乙肝疫苗采用肌肉和皮内混合免疫的方法,给绵羊接种。全程免疫 3次,6 mo后,取血及脾脏,分离白细胞,用离心和超滤的方法,提取转移因子,制成口服液,并对其所含成分、性质进行了研究。结果表明,该口服液的主要成分为核苷酸、多肽,并含有18种游离氨基酸,包括人体必需的8种氨基酸以及人体所必需的6种常量和微量元素。动物实验表明,无毒、无任何副作用。活性玫瑰花和~3H-TdR掺入法测定的淋巴细胞转化实验表明,该口服液具有转移因子注射制剂促进T淋巴细胞增殖和依赖于乙肝抗原的免疫活性,并可在不同动物间转移免疫活性。     

严重急性呼吸综合征冠状病毒特异转移因子的制备及其免疫活性研究

目的制备严重急性呼吸综合征 (SARS)冠状病毒特异转移因子并探讨其免疫学活性。方法以灭活的SARS冠状病毒免疫健康猪 ,取免疫后猪的脾脏和淋巴结 ,透析法提取转移因子 ,并作相应检测。通过巨噬细胞吞噬功能试验和白细胞黏附抑制试验探讨该品的免疫学活性。结果各项检测合格。巨噬细胞吞噬功能试验证明该品能促进巨噬细胞吞噬功跑。白细胞黏附抑制试验显示该品能提高未黏附白细胞抑制指数。结论SARS冠状病毒特异转移因子具有免疫增强作用和特异的免疫活性。     

小鼠白细胞粘附抑制试验测定抗乙肝转移因子特异免疫活性

目的 :研究抗乙肝转移因子特异免疫活性测定方法。方法 :采用小鼠脾淋巴细胞经抗乙肝转移因子体外致敏 ,再与HBsAg接触而产生白细胞粘附抑制反应。结果 :抗乙肝转移因子与普通转移因子相比 ,使未粘附白细胞显著增多 (P <0 .0 1) ,未粘附抑制指数达 82 %。结论 :此法可作为一种检测抗乙肝转移因子特异免疫活性的实用方法。     

转移因子在移植免疫中的作用

转移因子参与移植免疫的迟发型超敏反应。业已证明,移植皮肤4～6天后就有转移因子产生,并保持其活性达40天。以不同方法,包括皮内法给动物注射转移因子能改变移植物排斥速率。注射纯转移因子能加     

令人瞩目的转移因子

转移因子(TF)为一种免疫调节剂,有特异性及非特异性二种,且制备简单。近已证实无种属特异性,因此其制品源源不断,我国在这方面已取得不少进展,牛脾转移因子(BTE)制剂得到医药部门的正式批准,BTF及猪脾转移因子治疗流行性出血热、乙型肝炎、水痘、精神分裂症、再生障碍性贫血、支气管哮喘、慢性支气管炎、过敏性鼻炎、扁桃体炎、多发性神经炎、硬皮病以及声带息肉等疾病均取得令人瞩目的疗效。本文将其成就加以概述,以献给1988年将在北京召开的第六届国际TF学术会议。     

Lipo-NSAID preparation

Many studies have been recently devoted to the development of new administration routes and preparations based on the concept of drug delivery systems. Lipo-preparation, a new preparation in which lipid microsphere (LM) is utilized as a drug carrier, has been found to be preferentially delivered to lesion tissues, enabling enhancement of a drug's effects and reduction of its adverse reactions. Flurbiprofen axetil is a lipo-preparation. It is a pro-drug developed to reduce gastric mucomembranous disturbances caused by flurbiprofen, a widely-used oral nonsteroidal antiinflammatory drug and also to potentiate the analgesic effect of flurbiprofen. The pro-drug is intravenously injectable since flurbiprofen has been enclosed in lipid microspheres. It has been demonstrated in clinical trials that the pro-drug with strong and immediate analgesic effects is highly useful in relieving postoperative and carcinomatous pain. Flurbiprofen axetil, a lipo-NSAID preparation currently applied in clinical practice, is reviewed below.     

医疗机构制剂委托配制的分析

目的:根据近年来医院制剂发展现状,并结合2010-2014年某三甲中医医院受委托生产医院制剂情况进行分析,探讨在工业化大生产下医院制剂的生存之路。方法:通过文献调查了解医疗机构制剂发展状况,以及实际调查部分医疗机构制剂委托配制情况,掌握现阶段医疗机构制剂生存的特点。结果:医疗机构制剂呈现持续萎缩趋势,委托配制是医院制剂保持生存的重要方式之一,但是委托配制制剂流程复杂,周期长,效率低,利润少,大部分医疗机构利用委托配制制剂政策仅为了保留制剂文号。结论:委托配制为医疗机构制剂的生存提供了条件和途径,但需进一步改进、规范和政策调控,才能有效促进制剂发展。     

Development of a topical niosomal preparation of acetazolamide: preparation and evaluation

Orally administered acetazolamide has a limited use in glaucoma due to the systemic side effects associated with its use. No topical formulation of acetazolamide is available, mainly because of it having a limited aqueous solubility and poor corneal permeation. To enhance the bioavailability of acetazolamide by the topical route and to improve the corneal permeability of the drug, niosomes of acetazolamide were prepared (employing span 60 and cholesterol) by different methods. Transmission electron microscopy (TEM) of the selected formulation was carried out to study the morphology. Niosomes were also prepared in the presence of dicetyl phosphate and stearylamine to obtain negatively and positively charged vesicles, respectively. It was found that the reverse-phase evaporation method (REV) gave the maximum drug entrapment efficiency (43.75%) as compared with ether injection (39.62%) and film hydration (31.43%) techniques. Drug entrapment efficiency varied with the charge and the percent entrapment efficiency for the REV method was 43.75, 51.23 and 36.26% for neutral, positively charged and negatively charged niosomes, respectively. Corneal permeability studies, however, showed that the percent permeation and the apparent permeability coefficient for the charged niosomes were less than for the neutral ones. A bioadhesive niosomal formulation of acetazolamide was also prepared and compared with the positively charged formulation, considering that both of them would have a prolonged stay in the cul-de-sac because of their expected interactions with mucin. The formulations were also compared based on their intraocular pressure (IOP)-lowering capacity. The positively charged niosomes (REV2), although showing good corneal permeability and pharmacodynamics, were however found to be inappropriate in terms of the corneal cell toxicity. The bioadhesive coated formulation (REV1bio) compared well with REV2 and also showed a much lesser toxicity. Further, the IOP-lowering effect of the developed formulations was compared with that of a marketed formulation of dorzolamide 2%, a topical carbonic anhydrase inhibitor. The developed niosomal formulations of acetazolamide showed a comparable physiological effect (33% reduction of IOP in REV1bio and 37% reduction in dorzolamide) with a duration of up to 6 h (the duration being 3 h for dorzolamide). Results of the study indicate that it is possible to develop a safe (as indicated by corneal toxicity studies) and physiologically active topical niosomal formulation of acetazolamide relative in efficiency to the newer local carbonic anhydrase inhibitor, dorzolamide. The developed formulations can form a cost effective treatment plan, which is especially important in the treatment of glaucoma, a chronic ailment affecting middle-aged to old patients.     

漂浮-生物黏附协同作用制剂的研究进展

目的介绍漂浮-生物黏附协同作用制剂研究进展。方法对漂浮-生物黏附协同作用制剂的作用特点、制备方法及体外评价方法进行综述。结果该制剂可以延长药物在胃内的滞留时间,提高生物利用度。结论随着研究的深入,漂浮-生物黏附制剂将逐步受到重视,成为常用的药物新剂型之一。     

透皮吸收制剂的研究进展

目的:综述近年来透皮吸收制剂的研究进展.方法:以国内外大量有代表性的论文为基础,进行分析、整理和归纳.结果:透皮吸收制剂在促渗方法、使用材料等方面获得了很大的发展,制剂的皮肤渗量增大,渗透速率提高,上市产品增多.结论:透皮吸收制剂具有广泛的研究和应用前景.     

米氮平的合成

目的：合成去甲肾上腺素能和特异性5-羟色胺能抗抑郁药米氮平。方法：以苯甲酰甲酸甲酯和N-甲基乙二胺为原料经环合、还原、N-烷基化、水解、还原制得米氮平，并通过改变反应溶剂、催化剂和结晶试剂以及后咎理对其合成工艺进行改进。结果：得到的产品经IR，^1H-NMR，MS和元素分析，证明是米氮平。结论：本法收率和质量都有明显提高。