Effect of Glass Transition Temperature on the Stability of Lyophilized Formulations Containing a Chimeric Therapeutic Monoclonal Antibody

Purpose. The purpose of this study is to highlight the importance of knowing the glass transition temperature, T_g, of a lyophilized amorphous solid composed primarily of a sugar and a protein in the interpretation of accelerated stability data. Methods. Glass transition temperatures were measured using DSC and dielectric relaxation spectroscopy. Aggregation of protein in the solid state was monitored using size-exclusion chromatography. Results. Sucrose formulation (T_g ~ 59°C) when stored at 60°C was found to undergo significant aggregation, while the trehalose formulation (T_g ~ 80°C) was stable at 60°C. The instability observed with sucrose formulation at 60°C can be attributed to its T_g (~59°C) being close to the testing temperature. Increase in the protein/sugar ratio was found to increase the T_gs of the formulations containing sucrose or trehalose, but to different degrees. Conclusions. Since the formulations exist in glassy state during their shelf-life, accelerated stability data generated in the glassy state (40°C) is perhaps a better predictor of the relative stability of formulations than the data generated at a higher temperature (60°C) where one formulation is in the glassy state while the other is near or above its T_g.     

异常孕产史妇女风疹病毒感染的研究

目的了解孕妇风疹病毒的感染率；为早期预测异常妊娠的出现、及时防治提供理论依据。方法采用酶联免疫吸附法（ＥＬＩＳＡ）检测２０６例有异常孕产史妇女和８１０例正常孕妇血清中特异性抗风疹ＩｇＭ抗体。结果有异常孕产史的妇女风疹病毒感染率明显高于对照组（ｘ２＝１１．３３Ｐ＜０．０１）。结论风疹病毒感染是造成异常妊娠的主要原因之一；孕前或孕早期进行风疹病毒感染的检测，对降低异常妊娠的出现具有重要意义。     

肺结核病人红细胞免疫功能及T淋巴细胞亚群的变化

①目的探讨红细胞免疫功能及Ｔ淋巴细胞亚群变化与肺结核的关系。②方法对４４例肺结核病人和４４例健康人的红细胞免疫功能、血清循环免疫复合物、Ｔ淋巴细胞亚群、ＮＫ细胞水平的变化进行了检测，并与对照组比较。③结果肺结核病人红细胞Ｃ３ｂ受体花环率（Ｅ－Ｃ３ｂＲＲ），ＣＤ４，ＣＤ４／ＣＤ８，ＮＫ细胞水平明显降低，ＣＤ８水平明显升高，与对照组相比，差异均有极显著意义（ｔ＝９．７６～２２．２４，Ｐ均＜０．０１）；复治组较初治组变化更明显（ｔ＝４．２７～１５．３２，Ｐ均＜０．０１）。Ｅ－Ｃ３ｂＲＲ与ＣＤ４，ＣＤ４／ＣＤ８，ＮＫ细胞水平呈正相关（ｒ＝０．２６９２～０．５４７９，Ｐ＜０．０５，０．０１），与ＣＤ８呈显著负相关（ｒ＝－０．３７４，Ｐ＜０．０１）。④结论红细胞免疫功能、Ｔ淋巴细胞亚群及ＮＫ细胞的异常与肺结核的发病及病情变化有一定关系。     

Disorders in early embryonal cellular proliferative properties distort the postnatal formation of nervous, immune, and endocrine regulation systems in a newborn

Disorders in the postnatal nervous, immune, and endocrine regulation systems were revealed in the progeny of rats irradiated during the preimplantation period of embryogenesis. These disorders persist till adult age. The direction of disorders confirms the hypothesis about memorization of changed proliferative properties of embryonal cells during the development of the (pro)endocrine system of a new organism. Memorization results in distortion of postnatal nervous immunoendocrine regulation: hypertrophy of the endocrine component and coadaptive underdevelopment of the nervous and immune components. Translated fromByulleten' Eksperimental'noi Biologii i Meditsiny, Vol. 126, No. 8, pp. 164–166, August, 1998     

红细胞不同温度长期冻存后形态和免疫功能的变化及其临床意义

目的 探讨一种简便、有效的红细胞长期保存的方法。方法 红细胞在－40℃、80℃及－196℃（液氮）不同温度下长期保存18个月后，分别测定冻存前后红细胞平均体积（MCV）、红细胞渗透脆性（RFT）及红细胞免疫功能（RBC－C3bRR、ERPN）。结果 红细胞－40℃长期冻存后，MCV和RFT较冻存前显著提高（P＜0.05)，RBC－C3bRRt ERPN较冻存前显著降低（P＜0.05)。红细胞－80℃、－196℃长期冻存后，MCV、RFT、RBC－C3bRR及ERPN较冻存前无明显改变（P＞0.05)。结论 红细胞经－80℃、－196℃长期冻存后，其形态、结构和免疫功能保存良好。－80℃低温冻存是一种简便、有效的红细胞长期保存的方法。     

抗莱氏支原体单克隆抗体的研制

通过细胞融合技术，筛选出ＭＡＬ－１和ＭＡＬ－２两株抗莱氏支原体（Ａ．Ｌａｉｄｌａｗｉｉ，Ａ．Ｌ）单克隆抗体（单抗）。通过ＳＤＳ－ＰＡＧＥ和Ｗｅｓｔｅｒｎ印迹法测得单抗相对应的抗原分子量均为６７．４６ｋｕ。用间接免疫荧光法（ＩＦＡ）检测，单抗与细胞培养中另外３种常见污染的支原体和呼吸道肺炎支原体无交叉反应。将单抗用于检测支原体污染的细胞培养物，结果表明，此单抗能特异性地检出莱氏支原体。故可用其推断支原体污染途径，便于制定防治措施。     

指末端毛细血管血检测CMV抗体的研究

本文用ELISA方法对110名住院病儿指末端毛细血管血和静脉血配对血标本中巨细胞病毒(CMV)抗体进行了对照研究。配对血标本检测CMV IgM、IgG抗体的一致性分别为99.09％和96.36％;敏感性分别为87.5％和95.58％;特异性分别为100％和98.48％。反复多次重复检测配对血标本中CMV抗体,结果均呈正相关。本结果表明:指末端毛细血管血可代替静脉血检测儿科病血中CMV抗体.这对儿科CMV感染病儿进行动态血清学监测具有重要意义。     

Role of immune complexes in thyroid diseases

Institute of Biochemistry, Academy of Sciences of the Uzbek SSR, Tashkent. (Presented by Academician of the Academy of Medical Sciences of the USSR Yu. A. Pankov.) Translated from Byulleten' Éksperimental'noi Biologii i Meditsiny, Vol. 113, No. 2, pp. 168–170, February, 1992.     

抗蚊媒中肠抗体对冈比亚按蚊生殖率和死亡率影响的研究

目的探讨冈比亚按蚊中肠抗原抗媒介免疫的作用,进一步研究抗媒介疫苗抗原. 方法解剖室内饲养的冈比亚按蚊雌蚊中肠,立即置于冷的pH 7.4 PBS溶液中,用SDS-PAGE方法获得分子质量为43 ku中肠蛋白抗原,皮下注射免疫大白兔3次,获得的免疫血浆膜饲冈比亚按蚊成蚊,与对照组比较,观察其对冈比亚按蚊死亡率和生殖率的影响. 结果膜饲免疫血浆的冈比亚按蚊的死亡率与对照组相比显著增高,死亡率增加56%;生殖率明显下降,实验组蚊虫平均产卵率为71.4个,对照组为88.1个,下降18.7%. 结论采用有效的方法分离蚊媒中肠的关键性抗原-中肠蛋白抗原可能成为抗蚊媒和其它抗媒介疫苗的靶抗原.