轻身减肥片质量标准的研究

目的:建立轻身减肥片(黄芪、大黄、菌陈、丹参、山楂等)的质量标准.方法:对黄芪、大黄、菌陈、丹参、山楂等组分进行薄层色谱鉴别.采用高效液相色谱法对方中君药大黄中大黄素和大黄酚进行含量测定;结果:薄层图谱斑点清晰,阴性对照无干扰.大黄素、大黄酚平均加样回收率分别为100.3%、100.5%,RSD分别为1.5%、1.6%.结论:方法准确,方法重复性好,可作为该制剂的质量控制指标.     

中药新药试行标准转正的稳定性试验问题探讨

本文从企业申请中药新药试行标准转为正式标准的材料中整理出一些具有代表性的、对药品稳定性考察不规范的实例进行了分析,指出了企业在稳定性试验中主要存在的问题;通过与规范实例的对照,强调了规范稳定性试验考察的重要性;最后,就企业进行药品有效期的预测试验提出了一些建议.     

肛疾舒洗剂质量标准研究

目的:研究肛疾舒洗剂的质量标准,以控制该制剂质量.方法:采用TLC法分别对大黄、黄柏、徐长卿、樟脑等进行定性鉴定,用分光光度法测定该制剂中有效成分总蒽醌的含量.结果:TLC鉴别专属性强,含量测定以大黄素为对照品,浓度在2.51～12.57μg·ml-1的范围内,线性关系良好,r=0.999 9;平均回收率为96.94%(n=5),RSD为0.86%.结论:本质量标准可有效控制该制剂的质量且方法简单,准确,实用.     

胆芩降压颗粒剂的质量标准

目的:建立胆芩降压颗粒剂的质量控制方法.方法:采用薄层色谱鉴别处方中的龙胆、大黄、黄芩、黄柏、栀子;用薄层扫描法测定胆芩降压颗粒剂中大黄素含量.结果:在薄层图谱中检出龙胆、大黄、黄芩、黄柏、栀子的特征斑点;方法学考察显示,大黄素点样量在0.248～1.24μg范围内显良好线性关系.大黄素平均回收率98.71%(n=5),RSD为2.37%.结论:本方法可作为本制剂的质量控制方法.     

妇科调经片质量标准研究

目的:制定妇科调经片(熟地黄、当归、白芍、川芎、延胡索等)质量标准.方法:采用薄层色谱法鉴别延胡索、川芎、香附、白术、甘草、芍药;高效液相色谱法测定阿魏酸的含量.结果:薄层色谱法清晰,阿魏酸对照品在进样量0.08064～0.4032μg范围内线性关系良好,其回归方程为:Y=106160.7124X-530.4998,r=0.9999,回收率98.35%,RSD为1.45%.结论:本法简便快速,重现性好,可用于本制剂的质量控制.     

清咽袋泡剂的制备及质量控制

目的 :制备清咽袋泡剂并建立其质量控制方法。方法 :用薄层色谱法对金银花、甘草进行鉴别 ,并测定主药材金银花中绿原酸的含量。结果 :绿原酸线性范围为1 2μg～4 8μg(r=0 9993) ,平均回收率为99 50 % ,RSD=2 39 %。结论 :本方法操作简便、结果可靠 ,适用于清咽袋泡剂的质量控制。     

药品质量标准中应关注的数学问题

衡量药品的品质是否符合药品标准的要求,常牵涉到许多数据,这些数据的数学内涵是否合理,就成为衡量的结果是否可靠的问题.文中对一些事例进行了分析,提出了一些需要关注的问题,并提出了需要改进的方法和方向.     

Inequalities in enrollment of women and racial minorities in trials testing uric acid lowering drugs

AimsWe investigated sex and racial inequalities in clinical trials testing serum uric acid (SUA) lowering drugs and analyzed the temporal trends of participation among the pre-specified demographic groups.Data were collected from publications of clinical trials testing SUA-lowering drugs. Linear regression analysis was performed to assess the relation between drug approval year and proportion of women and minorities enrolled in clinical studies.Data synthesisThe mean percentage enrollment of women in clinical trials significantly decreased over the time (r = −0.43, P-value = 0.02). Moreover, there was a statistically significant difference in mean percentage enrollment of women among trials testing different SUA-lowering drugs, with the highest representation in rasburicase (71.1%) and the lowest representation of women in dotinurad (0.8%). Over the time, also the mean percentage enrollment of racial minorities decreased, passing from 8.7% to 2.2% in a 10-year period.Women were proportionally underrepresented compared with their share of the population with asymptomatic hyperuricemia, overall (participation-to-prevalence ratio (PPR) = 0.34), in trials testing xanthine oxiase inhibitors (PPR = 0.38) and uricosurics (PPR = 0.29), and in trials with febuxostat, allopurinol, pegloticase, halofenate/arhalofenate, verinurad, lesinurad and dotinurad. Women were proportionally underreppresented also compared with their share of the population with gout, overall (PPR = 0.69) and in trials testing XOIs (PPR = 0.69), uricosurics (PPR = 0.68), and all SUA-lowering drugs excepted for rasburicase, pegloticase and topiroxostat.ConclusionsOur analysis shows that women and racial and ethnical minorities are underrepresented in controlled clinical trials testing SUA-lowering drugs, with similar pattern across drug classes.     

卫生行政处罚裁量标准制定过程中存在的问题及思考

卫生行政机关通过制定裁量标准等形式对行政处罚自由裁量权进行限制是必要的,但应正确把握对裁量权的限制程度,防止走向僵化.裁量标准制定主体的多元化带来了法制统一问题和低层级行政机关制定裁量标准是否合法的疑问.在具体裁量标准的制定中,还存在对法律越权变更、过于僵化、忽视部分裁量因素、不同地域差距过大等问题,需要进一步研究和思考.     

Blood-Brain Barrier Permeability of Asiaticoside,Madecassoside and Asiatic Acid in Porcine Brain Endothelial Cell Model

Neurotherapeutic potentials of Centella asiatica and its reputation to boost memory, prevent cognitive deficits and improve brain functions are widely acknowledged. The plant's bioactive compounds, i.e. asiaticoside, madecassoside and asiatic acid were reported to have central nervous system (CNS) actions, particularly in protecting the brain against neurodegenerative disorders. Hence, it is important for these compounds to cross the blood-brain barrier (BBB) to be clinically effective therapeutics. This study aimed to explore the capability of asiaticoside, madecassoside and asiatic acid to cross the BBB using in vitro BBB model from primary porcine brain endothelial cells (PBECs). Our findings showed that asiaticoside, madecassoside and asiatic acid are highly BBB permeable with apparent permeability (P_app) of 70.61 ± 6.60, 53.31 ± 12.55 and 50.94 ± 10.91 × 10^?6 cm/s respectively. No evidence of cytotoxicity and tight junction disruption of the PBECs were observed in the presence of these compounds. Asiatic acid showed cytoprotective effect towards the PBECs against oxidative stress. This study reported for the first time that Centella asiatica compounds demonstrated high capability to cross the BBB, comparable to central nervous system drugs, and therefore warrant further development as therapeutics for the treatment of neurodegenerative diseases.