中医药知识产权保护的现状及对策探讨

目的:探讨近年来中医药知识产权保护研究进展。方法:查阅中医药知识产权保护研究文献并进行整理汇总。探讨中医药专利保护、商标保护、著作权保护、商业秘密保护、中药品种保护、地理标志保护等近况,以及当前中医药知识产权保护存在的5个方面的问题。结果与结论:从5个方面提出了加强中医药知识产权保护的策略、措施和建议。提出要提高我国中医药知识产权保护整体水平,尚需继续努力。     

中药的保护方式及相关法律法规简介

本文介绍了适用于中药的七种保护方式及相应的法律法规,并简要分析了商业秘密保护、国家秘密保护、商标保护、原产地域产品保护与原产地标记、专利保护、新药保护与新药监测、中药品种保护的特点,可供中药科研、生产、经营、使用单位和管理部门参考。     

中药的七种保护方式与有关法律法规简介

本文介绍了适用于中药的七种保护方式及相应的法律法规,并简要分析了商业秘密保护、国家秘密保护、商标保护、原产地域产品保护与原产地标记、专利保护、新药保护与新药监测、中药品种保护的特点,可供中药科研、生产、经营、使用单位和管理部门参考.     

药品试验数据保护对完善中药品种保护制度的启示

为进一步完善中药品种保护制度,本文运用药品试验数据保护的原理,探讨了未来中药品种保护的保护对象、保护措施、保护时间、保护品种的管理等,在切实保护我国中药的创新发展、充分发挥中医药在医疗体系中的作用、进而丰富中药品种保护制度的修订思路方面进行了有益的探索。     

中药知识产权保护主体的探讨

目的:探讨国家政府、中药企业及中医药从业者在中药知识产权保护中的关系。方法:本文从知识产权的理论入手,分析我国中药知识产权保护主体的现实组成,探寻市场经济中的保护主体。结果:中药知识产权应该由政府、行业及中医药从业者共同通过国家中药知识产权法律保护、行政保护以及中药行业保护等手段进行立体地保护。结论:中药企业为中药知识产权保护的利益主体,政府是中药知识产权保护行政主体。     

中药国际化迫切需要加大中药知识产权保护力度

针对迫在眉睫的中药知识产权保护问题，从中药知识产权的专利保护、商标保护、行政保护、商业秘密保护、新药保护五个方面，详析我国中药知识产权保护工作的现状及存在的问题，并提出加强中药知识产权保护的对策。     

中药专利保护对中药品种保护的辅助作用分析

为了更好、更有效地保护中药的知识产权,使国内中药产品走向国际市场,本文对中药品种保护和专利保护进行详细分析,比较中药专利保护和中药品种保护之间的优劣势,以便能够结合两者的优势,灵活运用这两种保护制度,达到最佳保护中药知识产权的目的.     

行政保护视角下我国中药品种保护制度中几个问题的探讨

中药品种保护制度是依据国务院颁布的《中药品种保护条例》而实施的药品行政保护制度。该文从药品行政保护含义与类别出发,对中药品种保护制度所涉及对象、客体和核心进行深入分析,指出中药品种保护制度作为行政保护的实质,并提出《中药品种保护条例》修订的建议。     

急诊妇产科患者隐私权保护调查分析

目的:探讨急诊妇产科患者隐私权保护现状,分析原因,提出改进保护隐私权的措施.方法:自行设计问卷调查表,对600例急诊妇产科患者进行隐私权保护状况的调查.结果:大部分患者认为:在医院隐私权缺乏保护;隐私权缺乏保护的环节主要有:学生带教、询问病史、查房、化验等.结论:护士应提高保护急诊妇产科患者隐私权的意识,并采取一系列措施加以保护.     

中药创新药知识产权综合性保护体系的初探——基于以岭药业连花清瘟方的实证分析

中药复方的创新是中医药的研究热点,目前创新主体缺乏系统性策略来灵活运用各种形式的保护制度,在现行法律及规范下,研究中药创新药的知识产权综合性保护体系是有必要的。本文运用了实证分析的方法,通过深度挖掘以岭药业涉及连花清瘟方的专利、行政保护、商标、外观设计等情报信息,对于完善中药创新药知识产权综合性保护体系进行了初探。创新主体应当灵活运用行政保护、专利、商业秘密制度,将各种保护制度有机衔接,从而进行更为全面、系统综合保护。     

Third-generation antiepileptic drugs: mechanisms of action,pharmacokinetics and interactions

This review briefly summarizes the information on the molecular mechanisms of action, pharmacokinetic profiles and drug interactions of novel (third-generation) antiepileptic drugs, including brivaracetam, carabersat, carisbamate, DP-valproic acid, eslicarbazepine, fluorofelbamate, fosphenytoin, ganaxolone, lacosamide, losigamone, pregabalin, remacemide, retigabine, rufinamide, safinamide, seletracetam, soretolide, stiripentol, talampanel, and valrocemide. These novel antiepileptic drugs undergo intensive clinical investigations to assess their efficacy and usefulness in the treatment of patients with refractory epilepsy.     

Biomedical applications of selective metal complexes of indole,benzimidazole, benzothiazole and benzoxazole: A review (From 2015 to 2022)

Indole, benzoxazole benzothiazole and benzimidazole are excellent classes of organic heterocyclic compounds. These compounds show significant application in pharmacy, industries, dyes, medicine, polymers and food packages. These compounds also form metal complexes with copper, zinc, cadmium, nickel, cobalt, platinum, gold, palladium chromium, silver, iron, and other metals that have shown to be significant applications. Recently, researchers have attracted enormous attention toward heterocyclic compounds such as indole, benzimidazole, benzothiazole, benzoxazole, and their complexes due to their excellent medicinal applications such as anti-ulcerogenic, anti-cancer, antihypertensive, antifungal, anti-inflammatory, antitubercular, antiparasitic, anti-obesity, antimalarial, antiglycation, antiviral potency, antineuropathic, analgesic antioxidant, antihistaminic, and antibacterial potentials. In this article, we summarize the medicinal applications of these compounds as well as their metal complexes. We hope this article will help researchers in designing and synthesizing novel and potent compounds with significant applications in various fields.     

A pilot study of heavy metal concentration in various environments and fishes in the Upper Sakarya River Basin,Turkey

In this study, concentration of lead, cadmium, copper, cobalt, nickel, and manganese were measured in water, sediment, and fish (Cyprinus carpio and Barbus plebejus) samples at the upper Sakarya river basin in Sept. 1995–1996 period. Also, physical parameters of selected stations in the Sakarya river were measured. Mean concentrations of lead, cadmium, copper, nickel, and manganese differed between water, sediment, and fish samples by seasons. Mean concentrations of lead, cadmium, and cobalt increased in sediment samples in October and August. In water samples only cadmium and cobalt increased in October whereas lead and copper increased in August. Also, high levels of manganese concentrations were detected in water and sediment samples and fish tissue during the study. ©1999 John Wiley & Sons, Inc. Environ Toxicol 14: 367–373, 1999     

Relative in vitro affinity of hepatic metallothionein for metals

The ability of selected metals (Ag, Al, As, Ca, Cd, Co, Cr, Cu, Fe, Hg, Mg, Mn, Mo, Ni, Pb, Tl and V) to displace Zn from Zn-metallothionein (Zn-MT) was quantitated. Of the metals tested Cd had the highest affinity for MT, with 1.33 microM displacing 50% of the 65Zn bound to MT (EC50), followed by Pb (1.46 microM), Cu (1.93 microM), Hg (3.93 microM), Zn (8.06 microM), Ag (10.4 microM), Ni (474 microM) and Co (880 microM). As, Ca and Mo had a limited ability to displace Zn from MT while Al, Cr, Fe, Mg, Mn, Tl and V had no effect on Zn binding even at 1.0 mM.     

苦参碱类生物碱免疫促进作用的研究进展

苦参碱类生物碱具有广泛的生物活性,如保护心、肝、肺、肾、脑、血管作用,对心脏有正性肌力、负性频率、抗心律失常作用,还有升高白细胞,平喘,抗溃疡,抗肝纤维化以及镇静、催眠、镇痛等中枢神经药理作用,也具有抗肿瘤、免疫调节、抗菌、抗病毒、抗炎等药理作用。苦参碱类生物碱对机体免疫功能具有双向调节作用,在高剂量时表现为免疫抑制作用,在低剂量时表现为免疫促进作用。综述氧化苦参碱、苦参碱、槐定碱和槐果碱的免疫促进作用,为进一步开发研究和临床应用提供参考。     

Novel modes of antifungal drug administration

Administration of antifungals by routes other than that for which the agent was designed or approved have been utilised in attempts to provide directed therapy, reduce adverse effects and improve drug penetration into selected infection sites, such as the central nervous system, lungs and peritoneum. The most widely investigated agent utilising a novel method of drug delivery is amphotericin B. Dose forms for this agent include topicals (aerosol, nasal spray, irrigations, pastes, absorbable sponges, impregnated bone cement and gelatin), oral dosage forms (solutions, suspensions, tablets and so on) and ophthalmic preparations (drops, ointments and injections). Amphotericin B has been administered by routes such as oral, endobronchial, intrathecal, intracisternal, intra-articular, intraperitoneal, ophthalmic and as an antibiotic ‘line lock’. Nystatin has been administered as an aerosol, percutaneous paste and bladder washes. Azoles, such as miconazole, fluconazole, ketoconazole and posaconazole, have been administered by novel methods but to a lesser degree. Most of these reports involve miconazole. The dose forms and routes of administration for azoles have included irrigants (bladder, joint), ophthalmic preparations (eye drops, intraocular injections, ointments), impregnated bone cement, endobronchial and intrathecal administration. Finally, both methylene blue (bladder washes) and flucytosine (peritoneal lavage, ophthalmic eye drops) have also been employed. Adequate evaluations of both the safety and efficacy of these therapies are most often hindered by prior or concomitant antifungal therapies, comorbidities and the lack of controlled clinical trials. In addition, the availability of newer treatment options, which demonstrate significant improvement in drug distribution and treatment-related adverse effects make many such novel modes of administration less practical or necessary. In contrast, the inhalation of antifungal aerosols, such as amphotericin B, is rapidly becoming a viable prophylactic option.     

Pediatric Obesity: Pharmacokinetic Alterations and Effects on Antimicrobial Dosing

Limited data exist for appropriate drug dosing in obese children. This comprehensive review summarizes pharmacokinetic (PK) alterations that occur with age and obesity, and these effects on antimicrobial dosing. A thorough comparison of different measures of body weight and specific antimicrobial agents including cefazolin, cefepime, ceftazidime, daptomycin, doripenem, gentamicin, linezolid, meropenem, piperacillin‐tazobactam, tobramycin, vancomycin, and voriconazole is presented. PubMed (1966–July 2015) and Cochrane Library searches were performed using these key terms: children, pharmacokinetic, obesity, overweight, body mass index, ideal body weight, lean body weight, body composition, and specific antimicrobial drugs. PK studies in obese children and, if necessary, data from adult studies were summarized. Knowledge of PK alterations stemming from physiologic changes that occur with age from the neonate to adolescent, as well as those that result from increased body fat, become an essential first step toward optimizing drug dosing in obese children. Excessive amounts of adipose tissue contribute significantly to body size, total body water content, and organ size and function that may modify drug distribution and clearance. PK studies that evaluated antimicrobial dosing primarily used total (or actual) body weight (TBW) for loading doses and TBW or adjusted body weight for maintenance doses, depending on the drugs’ properties and dosing units. PK studies in obese children are imperative to elucidate drug distribution, clearance, and, consequently, the dose required for effective therapy in these children. Future studies should evaluate the effects of both age and obesity on drug dosing because the incidence of obesity is increasing in pediatric patients.     

国内对头孢克肟的临床研究与评价

头孢克肟是第1种第3代口服头孢菌素类抗生素,由日本藤泽制药株式会社于1987年研制成功并首先在日本上市应用于临床,1989年在美国上市。1999年已在80多个国家得到广泛的临床使用。头孢克肟的制剂剂型的研究已发展有胶囊剂、颗粒剂、混悬剂、片剂(普通片剂、咀嚼片、分散片)等。笔者综述了国产头孢克肟与日本产头孢克肟在胶囊剂、颗粒剂、混悬剂、片剂(普通片剂、咀嚼片、分散片)等的药动学比较,以及头孢克肟与头孢泊肟、头孢克洛、头孢呋辛、头孢美他酯、头孢噻肟、头孢地尼、头孢特仑、头孢妥仑匹酯等体外抗菌活性及临床药效学比较。     

消风止痒颗粒中毛蕊花糖苷、焦地黄苯乙醇苷B1、升麻素苷、升麻素、5-O-甲基维斯阿米醇苷、亥茅酚苷、苍术素醇、白术内酯Ⅱ和苍术素的HPLC法测定及其化学计量学综合评价

目的建立HPLC法同时测定消风止痒颗粒中毛蕊花糖苷、焦地黄苯乙醇苷B1、升麻素苷、升麻素、5-O-甲基维斯阿米醇苷、亥茅酚苷、苍术素醇、白术内酯Ⅱ和苍术素,并采用化学计量学方法对检测结果进行综合评价。方法采用Agilent Zorbax SB-C18色谱柱(250 mm×4.6 mm,5μm);以乙腈-0.2%磷酸溶液为流动相,梯度洗脱;检测波长:330 nm(0~14 min检测毛蕊花糖苷和焦地黄苯乙醇苷B1)、254 nm(14~31 min检测升麻素苷、升麻素、5-O-甲基维斯阿米醇苷和亥茅酚苷)、270 nm(31~55 min检测苍术素醇、白术内酯Ⅱ和苍术素);体积流量0.9 mL/min;柱温25℃;进样量10μL。采用SPSS26.0统计软件对消风止痒颗粒中9种成分进行聚类分析和主成分分析。结果毛蕊花糖苷、焦地黄苯乙醇苷B1、升麻素苷、升麻素、5-O-甲基维斯阿米醇苷、亥茅酚苷、苍术素醇、白术内酯Ⅱ和苍术素分别在2.53~63.25、1.09~27.25、8.17~204.25、2.38~59.50、4.07~101.75、1.74~43.50、0.66~16.50、1.47~36.75、2.86~71.50μg/m L线性关系良好;平均回收率分别为99.01%、98.17%、100.13%、97.63%、98.72%、97.22%、96.93%、99.24%、100.01%,RSD值分别为1.42%、1.26%、0.72%、1.55%、0.84%、1.06%、1.18%、0.67%、0.95%;11批样品聚类分析为3类,主成分1~3是影响消风止痒颗粒质量评价的主要因子。结论该方法操作简便、重复性好,可作为消风止痒颗粒中多指标成分质量评价模式。     

A comparison of the efficacy of cilazapril versus cilazapril plus hydrochlorothiazide in patients with mild to moderate essential hypertension

Summary The efficacy of cilazapril monotherapy and in combination with hydrochlorothiazide 12.5 mg was compared in a multicentre, double blind, randomised parallel group study in 87 patients with mild to moderate essential hypertension over 8 weeks. After a 2 week single blind placebo run-in period, patients received either 2.5 mg cilazapril or 2.5 mg cilazapril plus 12.5 mg hydrochlorothiazide once daily. At Week 4 the cilazapril dose was increased from 2.5 mg to 5.0 mg if the mean sitting diastolic blood pressure was greater than 90 mmHg or had not decreased by more than 10 mmHg.After 8 weeks treatment 72% of patients responded to 2.5 mg cilazapril increasing to 88% with cilazapril 5.0 mg. For cilazapril plus hydrochlorothiazide, 83% responded to 2.5 mg cilazapril increasing to 96% on 5.0 mg cilazapril.The high response rate to low dose cilazapril monotherapy and hydrochlorothiazide combination therapy has important implications for minimising the cost of therapy with ACE inhibitors.Inhibace General Practice Study Group: Drs. Atkinson, Bevin, Choy, DeLacey, Dine, Doerr, Dykes, Eames, Edwards, Ford, Gare, Haycock, Haywood, Hendy, Hunter, Loan, Lowe, Mules, Nealie, Parker, Pollock, Rasalingham, Reekie, Richmond, Sandin, Staub, Suckling, Surynt, Vickers, Wellington, Wells, Wong and Young