Control of craving for methamphetamine: development of scales for dependence and search for medicines for treatment]

Methamphetamine dependence presents a serious problem not only for patients but also for society. Medical treatment has mainly targeted psychotic symptoms such as hallucination and delusion, and ignored the symptoms of craving, which are the major cause of dependence. Therefore, the risk of lapse into methamphetamine reuse remains very high. Although development of both medicines and programs for treatment of craving is needed, progress has been hampered by the lack of appropriate scales for assessing the severity of dependence and craving. On the other hand, recent breakthroughs in genomic sciences and molecular medicine have made it possible to investigate the molecular mechanisms underlying craving in animals. This paper reviews studies on the development of scales for assessing the severity of methamphetamine dependence and craving, together with recent data on candidate medicines for craving treatment in animals. The reliability and validity of the revised Addiction Severity Index -Japanese version (ASI-J) was confirmed after its administration to 100 drug abuse patients. The Craving Index was also newly developed, and its validity for prediction of relapse was confirmed. In animal experiments, fluoxetine, a selective serotonin reuptake inhibitor, was recognized as a candidate medicine for treatment of methamphetamine dependence.     

Selection of patients for surgery for primary aldosteronism

1. Primary aldosteronism is a condition characterized by renin suppression and various degrees of hypertension and hypokalemia caused by aldosterone hypersecretion. 2. The adoption of the aldosterone-to-renin ratio determination as a screening test has led to an increase in the prevalence of diagnosed cases of primary aldosteronism. 3. Primary aldosteronism is confirmed by the demonstration of either sustained absolute aldosterone hypersecretion, or non-suppressible aldosterone hypersecretion. 4. Computed tomography and adrenal vein sampling can then be used to distinguish between idiopathic primary aldosteronism and the surgically remediable forms: aldosterone-producing adenoma and primary adrenal hyperplasia. 5. In patients with aldosterone-producing adenoma or primary adrenal hyperplasia, unilateral adrenalectomy generally results in the normalization of aldosterone secretion and kalemia, but normotension is achieved in only half of the cases. Nevertheless, in many cases without hypertension cure, adrenalectomy leads to an improvement in hypertension control with lower blood pressure levels and/or less antihypertensive medication.     

注射用头孢吡肟安全性评价研究

目的 评价注射用头孢吡肟的安全性。方法 对注射用头孢吡肟进行了过敏性、溶血性及血管刺激性试验。结果 注射用头孢吡肟对兔耳缘静脉血管内皮没有损伤和刺激作用。与生理盐水对照组血管比较．两者无明显差异，对兔红细胞没有致溶血作用和凝聚作用，豚鼠未出现过敏反应。结论 注射用头孢吡肟对兔用药静脉血管无刺激性。也无溶血及红细胞凝聚作用。对豚鼠无致敏作用。该药相关安全性检测结果符合新药申报要求。     

注射用奥沙利铂无菌检查方法的验证

目的:建立注射用奥沙利铂无菌检查方法的验证。方法:直接接种法进行无菌检查,观察各种挑战微生物在样品试验组的生长情况。结果:均明显见微生物生长。结论:注射用奥沙利铂的无菌检查通过验证。     

注射用吡柔比星细菌内毒素检查法

目的确立注射用吡柔比星细菌内毒素检查方法.方法参照中国药典2000年版二部细菌内毒素检查法要求进行试验.结果该药在0.5 mg·ml-1浓度下不干扰内毒素试验.结论该药采用内毒素检查法代替热原检查法,方法可行.     

Research for development of immunoassay kits for hapten

Determination of estrogen concentrations in the urine is widely utilized for a variety of purposes, such as the assessing of fetoplacental unit function and ovarian function, and the monitoring of follicle in inducing ovulation in the treatment of infertility. Since hapten antigens such as estrogen have low molecular weight, unlike high molecular substances, they do not form visible agglutination of antigen-antibody reaction, so there has been no other choice but to depend on radioimmunoassay for the determination of estrogen concentrations. However, radioimmunoassay requires special facilities and apparatus and is complicated in procedure, and these drawbacks have prevented the estrogen assay from routine tests in spite of clinical usefulness. As a result of various researches, a new immunochemical principle called competitive agglutination inhibition reaction has been developed for the determination of hapten concentrations, and succeeded in putting this principle to practical use with a fetoplacental unit function test kit (Estrotec slide test) and highly sensitive semi-quantitative analysis kits for urinary estrogen (Hi-estrotec and Hi-estrotec slide).     

注射用头孢呋辛钠给药的安全性评价

目的:评价注射用头孢呋辛钠的给药安全性。方法:对注射用头孢呋辛钠进行了血管刺激性、过敏性和溶血性试验。结果:注射用头孢呋辛钠对免耳缘静脉血管内皮与生理盐水对照组血管比较,两者无明显差异;对兔红细胞没有致溶血作用和凝聚作用,豚鼠未出现过敏反应。结论:注射用头孢呋辛钠对兔静脉血管无刺激性,也无溶血及红细胞凝聚作用,对豚鼠无致敏作用。该药相关安全性检测为临床用药提供参考。     

注射用粉针溶液颜色限度的制订

本实验采用<中国药典>2000年版二部附录首次收载的溶液颜色检查第三法(色差计法),同时结合经典的目视法对一种抗生素注射用粉针的10批具有代表性的样品进行了溶液颜色的考察测定,并对测定数据进行置信区间的计算,从而较为科学合理地制订出其溶液颜色检查项的限度规定.     

注射用加替沙星与注射用法莫替丁的配伍稳定性考察

目的:考察注射用加替沙星与注射用法莫替丁在0.9%氯化钠注射液和5%葡萄糖注射液中的配伍稳定性。方法:在(20±1)℃条件下,分别观察及测定8h内配伍液的外观、pH值及紫外光谱的变化,并用紫外分光光度法测定加替沙星和法莫替丁的含量。结果:2药配伍后,8h内的pH值及含量均无明显变化;另在0.9%氯化钠注射液中8h内与5%葡萄糖注射液中6h内,配伍液的外观无明显变化。结论:注射用加替沙星与注射用法莫替丁在0.9%氯化钠注射液和5%葡萄糖注射液中配伍稳定。     

头孢呋辛酯干混悬剂溶出度测定方法的建立

目的 建立头孢呋辛酯干混悬剂溶出度测定方法.方法 采用浆法,以0.07mol·L-1的pH 7.0的磷酸缓冲液(称取3.7g磷酸二氢钠和5.7g无水磷酸氢二钠,加水1000mL使溶解)为溶剂,转速为50r·min-1,30min时取样.以紫外可见-分光光度法测定头孢呋辛酯的溶出度,检测波长为278nm.结果 头孢呋辛酯在3.36～20.16μg·mLl的浓度范围内,线性关系良好.平均回收率为99.7％(RSD=0.20％,n=12).结论 增加头孢呋辛酯溶出度检查项极为必要.本方法操作简便、结果正确,为完善头孢呋辛酯干混悬剂的质量标准提供了有效的手段.     

注射用七叶皂苷钠无菌检查方法学验证

目的建立注射用七叶皂苷钠的无菌检查方法,并对方法进行验证。方法按《中国药典》201O年版二部附录XIH无菌检查法进行方法学验证。结果用0．1％蛋白胨水溶液作稀释剂进行稀释,采用薄膜过滤法进行过滤,加相应的培养基进行培养,六株试验菌供试品阳性对照与阳性对照比较均生长良好,符合验证要求。结论验证所建立的方法可用于注射用七叶皂苷钠的无菌检查,结果准确、可靠。     

注射用兰索拉唑细菌内毒素检查法的可行性研究

目的对注射用兰索拉唑进行干扰试验,建立注射用兰索拉唑细菌内毒素检查的试验方法。方法采用《中国药典》2010年版二部附录细菌内毒素检查法进行试验。结果将注射用兰索拉唑稀释至浓度为50μg/ml时,对细菌内毒素检查法无干扰作用。结论应用鲎试剂进行注射用兰索拉唑细菌内毒素检查是可行的。     

Strategies for controlled delivery of biologics for cartilage repair

The delivery of biologics is an important component in the treatment of osteoarthritis and the functional restoration of articular cartilage. Numerous factors have been implicated in the cartilage repair process, but the uncontrolled delivery of these factors may not only reduce their full reparative potential but can also cause unwanted morphological effects. It is therefore imperative to consider the type of biologic to be delivered, the method of delivery, and the temporal as well as spatial presentation of the biologic to achieve the desired effect in cartilage repair. Additionally, the delivery of a single factor may not be sufficient in guiding neo-tissue formation, motivating recent research toward the delivery of multiple factors. This review will discuss the roles of various biologics involved in cartilage repair and the different methods of delivery for appropriate healing responses. A number of spatiotemporal strategies will then be emphasized for the controlled delivery of single and multiple bioactive factors in both in vitro and in vivo cartilage tissue engineering applications.     

Strategies for the targeted delivery of therapeutics for osteosarcoma

Background: Conventional therapy for osteosarcoma has reached a plateau of 60 – 70%, a 5-year survival rate that has changed little in two decades, highlighting the need for new approaches. Objective: To review the alternative means of delivering effective therapy for osteosarcoma that reach beyond the central venous catheter. Methods: Drawing on the author's own experiences providing care to high-risk osteosarcoma patients and reviewing the last two decades of literature describing sarcoma therapy, available information is summarized about potential osteosarcoma treatments that deliver therapy by a less conventional route. Results/conclusions: Intra-arterial chemotherapy has a limited impact on survival, but may help to achieve a better limb salvage. Intrapleural chemotherapy is important for managing malignant effusions. The development of inhalation therapies, treatments that target new bone formation such as bisphosphonates, chemically targeted radiation and antibody-based therapies all have potential to improve osteosarcoma therapy.     

FDA对治疗酗酒药物临床研究的要求

酗酒是世界范围内严重的公共卫生问题。目前治疗酗酒药物少而且疗效有限,亟待开发新的疗法与药品。美国食品药品管理局(FDA)于2015 年2 月发布了有关治疗酗酒药物临床研究的指导原则(草案),主要介绍了对这类药物临床研究的一般要求和对药效学研究的要求,建议采取持续6 个月的试验,并以在观察期间没有任何酗酒天数患者的比例(无酗酒天数的百分率)为主要终点。介绍该指导原则的主要内容,希望对我国这类药物的研究和注册审评有所帮助。     

滴眼用利福平含量测定用溶剂的探讨

目的：对滴眼用利福平含量测定用溶剂对含量的影响加以分析,在质量标准中详细说明滴眼用利福平供试品溶液制备方法是必要的。方法：色谱柱为Alltech Alltima C8（4．6mm×250mm,5μm）,柱温30℃,流动相为甲醇-乙腈-0．075mol·L^-1磷酸二氢钾溶液-1．0mol·L^-1枸橼酸溶液（30：30：36：4）,流速1．0mL·min^-1,检测波长254am,进样量10μL。结果：滴眼用利福平含量测定用溶剂对含量影响很大。结论：建议滴眼用利福平质量标准中的含量测定项下注明：对照品溶液的具体制备方法与溶液应在制备后立即进样,确保质量标准的可操作性。