头孢克罗缓释片的药物动力学和生物利用度研究

比较了头孢克罗缓释片和普通胶囊的药物动力学和生物利用度，８名健康志愿者随机交叉单剂量ｐｏ７５０ｍｇ缓释片和普通胶囊，采用ＨＰＬＣ法测定血浆和尿中头孢克罗浓度，缓释片和普通胶囊的药动学参数为Ｃｍａｘ７．２６±１．０８和１５．４４±３．７３μｇ／ｍｌ；Ｔｍａｘ１．１３±０．２３和０．７２±０．１６ｈ；ｔ１／２０．９４±０．１９和０．６３±０．０８ｈ；ＭＲＴ２．５１±０．４５和１．３５±０．２５ｈ，ＡＵＣ２１．６５±３．３１和２２．２４±３．６８ｈμｇ／ｍｌ。ＡＵＣ及其对数形式经三因素方差分析和双单侧检验，两种制剂均无显著性差异，缓释片的相对生物利用度为（９８．２３±１３．７３）％。     

盐酸丁咯地尔片的生物利用度及药代动力学研究

为比较国产盐酸丁咯地尔片剂和进口盐酸丁咯地尔（活脑灵）片剂的药代动力学参数,求出国产制剂的生物利用度,将１２ 名健康志愿者随机分为２ 组,分别单次口服国产盐酸丁咯地尔片及进口活脑灵片３００ｍ ｇ,用ＨＰＬＣ法测定血药浓度,采用３Ｐ９７ 程序处理实验数据,进行药代动力学和相对生物利用度研究。结果表明,口服国产和进口两种制剂的药时曲线均符合一室模型,血药峰浓度Ｃｍ ａｘ 分别为（１．９５±０．４２）ｍ ｇ／Ｌ和（２．００±０．５７）ｍ ｇ／Ｌ,达峰时间Ｔｐｅａｋ 分别为（２．４２±０．６３）ｈ 和（２．４８±０．４６）ｈ,药时曲线下面积ＡＵＣ分别为（１６．１６±３．４６）ｍ ｇ／Ｌ·ｈ 和（１６．２１±２．８２）ｍ ｇ／Ｌ·ｈ。两组参数差别均无统计学意义（Ｐ＞０．０５）。国产盐酸丁咯地尔片剂与进口活脑灵片剂相比,相对生物利用度为（１００．７±１９．１）％ ,两种片剂为生物等效制剂     

酮洛芬速溶颗粒剂人体药物动力学研究

对酮洛芬速溶颗粒剂进行了人体药物动力学研究。在体内试验中，选１０名健康受试者，采用交叉设计方案，以酮洛芬肠溶片为对照对颗粒剂做单剂量给药试验，建立了ＨＰＬＣ－ＵＶ法测定血浆中酮洛芬的浓度。结果显示，建立的酮洛芬血浆浓度测定方法，线性范围为０．５０～５０．０μｇ／ｍｌ，检测限为０．０６μｇ／ｍｌ。人体药动学结果显示：颗粒剂Ｔｍａｘ、Ｃｍａｘ及ＡＵＣ等主要药动学参数分别为０．５２ｈ，１３．６２μｇ／ｍｌ，２６．２９ｈ·μｇ／ｍｌ，肠溶片的相应参数分别为：３．３ｈ，６．５１μｇ／ｍｌ，２４．３２ｈ·μｇ／ｍｌ。与肠溶片比较，颗粒剂具有吸收速度快的特点。颗粒剂相对于肠溶片的生物利用度为１０６．４３％。经双单侧检验，属生物等效。     

高效液相色谱法测定舒他西林片中氨苄青霉素的血药浓度及药动学研究

采用ＨＰＬＣ－荧光检测法测定舒他西林片中氨苄青霉素的血药浓度，采用ＳｐｈｅｒｉｓｏｒｂＯＤＳ柱，流动相为磷酸盐缓冲液（０．０５ｍｏｌ／Ｌ，ｐＨ＝４．０）－乙腈（７８２２，Ｖ／Ｖ），标准曲线范围０．２２～１３．８９μｇ／ｍｌ，ｒ＝０．９９９７，保留时间为７．３ｍｉｎ，回收率大于９５％，日内和日间差小于７％，最低检测浓度为０．２２μｇ／ｍｌ，无内源性杂质干扰。９名受试者的主要药动学参数：Ｔ１／２＝１．０４±０．２２ｈ，Ｃｍａｘ＝１２．３５±３．１３μｇ／ｍｌ，Ｔｍａｘ＝０．８３±０．４５ｈ，ＡＵＣ＝１９．４９±３．４６μｇｈ／ｍｌ。     

对乙酰氨基酚溶液剂及其药物动力学研究

研制了对乙酰氨基酚溶液剂（５ｇ／０．１Ｌ），建立了高效液相色谱法（ＨＰＬＣ－ＵＶ）测定血药浓度。以Ｔｙｈｅｎｏｌ○Ｒ（ＭｃＮｅｉｌ，ＵＳＡ）混悬液为对照品，研究了自制对乙酰氨基酚溶液剂在８名健康志愿受试者体内的药物动力学。结果显示，对乙酰氨基酚溶液剂在人体内的动力学以二室线性模型描述为宜，其主要药物动力学参数分别为α＝０．６１５２ｈ－１，β＝０．１９２５ｈ－１，ｔ１２＝３．６２ｈ，Ｋａ＝３．８８６４ｈ－１，ＡＵＣ０→∞＝７７．２３ｈ·μｇ／ｍｌ，相对于Ｔｙｌｅｎｏｌ○Ｒ混悬剂的生物利用度为９８．８５％。     

酮洛芬缓释胶囊剂的生物利用度研究

８ 名健康受试者单剂量和多剂量交叉口服酮洛芬缓释胶囊的试验制剂和参比制剂。单剂量试验结果表明,达峰时间分别为５ ．６８ ±１ ．７３ ｈ 和６ ．５８ ±１ ．９２ ｈ ,峰浓度分别为３ ．９１ ±１ ．１３ μｇｍｌ 和３ ．１５ ±０ ．７９ μｇｍｌ ,两种制剂的药动学参数无显著性差异,试验制剂的相对生物利用度为（９９ ．９７ ±９ ．６３） ％ 。多剂量试验研究表明,试验制剂和对照制剂的波动系数分别为２ ．５６ ±０ ．４７ 和２ ．５５ ±０ ．７３ ,经统计学处理无显著性差异,表明两种制剂的安全性相当。     

HPLC法测定SHR血清中硝苯地平浓度及其药代动力学研究

目的建立血清中硝苯地平浓度的ＨＰＬＣ测定法，研究其在自发性高血压大鼠（ＳＨＲ）体内的药动学。方法ＳＨＲ灌胃给与硝苯地平１０ｍｇ／ｋｇ，用ＨＰＬＣ法测定硝苯地平血清浓度。用乙酸乙酯提取出血清中的硝苯地平，在５０℃水浴中用氮气吹干，残渣用流动相溶解后进样。选用ｓｈｉｍＰａｃｋＣＬＣ－ＯＤＳ柱，甲醇－水（６∶４）作流动相，检测波长２３５ｎｍ。结果：硝苯地平最低检出浓度为０．０２μｇ／ｍｌ，标准曲线线性范围为０．０２～５．０μｇ／ｍｌ（ｒ＝０．９９９７），血样平均回收率为９８．０９％。硝苯地平在大鼠体内的药动学符合一定开放模型，其参数为Ｔ１／２ｋａ＝０．８２８±０．５５ｈ，Ｔ１／２ｋｅ＝３．１７±２．３２ｈ，Ｔｍａｘ＝２．１２±１．４７ｈ，Ｃｍａｘ＝２．７８±１．５０μｇ／ｍｌ和ＡＵＣ＝２４．５±２９．２ｈ·μｇ／ｍｌ。结论本法能满足血清中硝苯地平浓度测定及药动学研究的需要。     

格列吡嗪胶囊的相对生物利用度及其生物等效性评价

１０名健康志愿者随机交叉ｐｏ单剂量１０ｍｇ格列吡嗪胶囊（国产）或片（进口）。利用ＨＰＬＣ测得血浆中药物浓度分别在２．５２±０．４２和２．７６±０．２０ｈ达到峰值６３２．９±１０５．８和６２０．０±１０４．９ｎｇ／ｍｌ。血药浓度－时间曲线下面积分别为４７６４．７±６５２．６和４６９５．９±６０１．０ｎｇ·ｈ／ｍｌ。药－时曲线符合一级吸收的单室模型。格列吡嗪胶囊的相对生物利用度Ｆ为１．０１±０．０７９，经统计分析两种制剂具有生物等效性。     

国产氨氯吡咪片的相对生物利用度及其生物等效性评价

６名健康志愿者随机交叉ｐｏ单剂量１０ｍｇ氨氯吡咪国产或进口片。利用ＨＰＬＣ测得血浆中药物浓度分别在３．１２±０．５０和３．０７±０．７１ｈ达到峰值２５．４±５．３和２１．８±８．９ｎｇ／ｍｌ。血药浓度－时间曲线下面积分别为２５３±６６和２２６±５６ｎｇ·ｈ／ｍｌ。药－时曲线符合一级吸收的单室模型，国产氨氯吡咪片的相对生物利用度Ｆ为１．１４±０．３４，经统计分析两种制剂具有生物等效性。     

萘普生缓释片的制备及其人体生物利用度研究

为减少萘普生普通片剂口服后对胃肠道的刺激性,制备了萘普生缓释片,研究了萘普生缓释片和普通片的药物动力学和生物利用度。通过体外溶出度的方法研究了缓释片的释药动力学,并采用ＨＰＬＣ法测定了普通片和缓释片口服后血浆中萘普生的浓度。结果表明,缓释片体外释放符合一级动力学过程。１０名健康志愿者随机交叉单剂量口服２×２５０ｍｇ萘普生缓释片和普通片,峰浓度（Ｃｍａｘ）分别为（５７．７９±７．３２）μｇ／ｍｌ和（６９．９０±１１．８８）μｇ／ｍｌ;缓释片与普通片的达峰时间（ｔｍａｘ）分别为（６．５±１．９）ｈ和（２．３±０．８）ｈ。结果表明,与普通片相比较,缓释片口服后能明显推迟达峰时间,并降低峰浓度（Ｐ＜０．０１）。缓释片与普通片的ＡＵＣ０→２４之间没有显著性差异（Ｐ＞０．０５）;缓释片相对于普通片的生物利用度为（１０８．５±１０．７）％。     

APPLICATION OF LORNOXICAM TO PATIENT-CONTROLLED ANALGESIA IN PATIENTS UNDERGOING ABDOMINAL SURGERIES

FOR anesthesiologis s ,treatingpostoperativepainhas alwaysbeen a problem.Althoughopioidshave been provedtobe effective,theirsideeffectscouldnotbeignored.With thedevelopmentofscienceand pharmacology,many drugs with aspectsof satisfactoryanalgesicefficacyand couldbe welltoleratedby patientshave been developed.And lornoxicamisone of them, which isa non-steroidalanti-inflammatorydrug (NSAID ), with analgesic, anti-infl-ammatory,andantipyreticproperties.Itseliminationhalf-time(3 to 5 hours) isle…     

Dr.Zhang Ren''''s Experience in the Acupuncture Treatment of Different Diseases with the Same Therapeutic Principle

Dr.Zhang Ren,the chief physician,is the chairman of Shanghai Acupuncture and Moxibustion Association.Having been engaged in medicine for about 40 years,he is experienced in treating various intractable diseases.In his long years of clinical practice,he advocates taking the TCM differentiation as the basis to seek for the acupuncture method for treatment of modern intractable diseases.The author of this essay had the fortune to follow Dr.Zhang in study.The following is a summary of Dr.Zhang's experience in the acupuncture treatment for different intractable diseases with the same therapeutic principle.     

Luo Lingjie''''s Experience in Treating Chronic Nephropathy

In treating chronic nephropathy,Luo Lingjie,a chief physician,pays attention to regulating the balance between yin and yang,treating infection if present,and removing pathogenic factors.He prescribes gentle drugs and uses carefully strongly warming-tonifying ones,emphasizes the importance of persuading the patient to persist in treatment with medication and nurse one's health for recuperation,and is good at combined use of TCM and western medicine therapy and brings the merits of various therapies into full play,with obvious theraoeutic effects.     

Acupuncture Combined with Spinal Tui Na for Treatment of Primary Dysmenorrhea in 30 Cases

Objective: To observe the therapeutic effects in acupunture treatment of primary dysmenorrhea combined with spinal Tui Na, and study its mechanism. Methods: Thirty cases of the treatment group were treated by acupuncture combined with spinal Tui Na, and thirty cases in the control group were treated by routine acupuncture. Results: The total effective rate was 93.3% in the treatment group, and 73.3% in the control group, with a significant difference between the two groups (P<0.05). Conclusions: Acupuncture combined with spinal Tui Na has good prospects for treatment of primary dysmenorrhea.     

猪肺磷脂注射液联合经鼻持续气道正压通气对呼吸衰竭早产儿的临床疗效及肌酸激酶同工酶活性的影响

目的 探讨猪肺磷脂注射液联合经鼻持续气道正压通气(NCPAP)对呼吸衰竭早产儿的临床疗效及肌酸激酶同工酶活性(CK-MB)的影响.方法 选取呼吸衰竭早产儿80例,分为观察组和对照组各40例.对照组采用NCPAP给氧治疗,观察组给予NCPAP给氧联合猪肺磷脂气管内给药.观察两组患儿治疗前及治疗12h、24 h后PaO2、PaCO2、血氧饱和度(SaO2)、pH的变化情况,检测治疗前及治疗5d后血清CK-MB水平;评估两组患儿的临床治疗效果.结果 两组患儿PaO2、PaCO2、SaO2、pH比较,差异均有统计学意义(P＜0.05),其中观察组治疗后的PaO2、SaO2、pH均高于对照组,PaCO2则低于对照组.两组的PaO2、SaO2、pH均随观察时间延长而升高(P＜0.05),PaCO2均随观察时间的延长而降低(P＜0.05).观察组治疗有效率为87.5％,显著高于对照组的70.0％ (P ＜0.05).治疗5d后两组患儿血清CK-MB水平均较前降低(P＜0.05),且观察组明显低于对照组(P＜0.05).结论 猪肺磷脂注射液气管内给药联合NCPAP可以显著降低呼吸衰竭早产儿CK-MB的含量,提高治疗有效率,起到很好的呼吸循环支持作用.     

Survey and practice of reporting quality of randomized controlled clinical trials on traditional Chinese medicine

Evidence obtained from randomized controlled trials （RCTs） has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully Jnderstand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner. Since 1998, we have conducted several evaluations on the reporting quality of RCTs published in Chinese journals on traditional Chinese medicine （TCM） and results have shown that there is an urgent need for higher quality RCTs on TCM.     

TCM Treatment of Ankylosing Spondylitis by Tonifying the Kidney and Strengthening the Governor Vessel

Ankylosing spondylitis is a chronic and progressive disorder with inflammation mainly involving the central axis joints. It mainly affects the cervical spine and the lumbosacral area, with the pathogenesis closely related to the kidney and the Governor Vessel (GV). TCM holds that the syndrome is deficiency in origin and excess in superficiality, which is due to insufficiency of the kidney, deficiency of GV, and blocking of the channels with the invasion of exogenous evil, leading to poor circulation of qi and blood and malnutrition of the bones, muscles and joints. The TCM method of tonifying the kidney and strengthening GV to regulate circulation of qi and blood and check the arthralgia pain should be adopted, with the Kidney-Tonifying and GV Strengthening Decoction (益肾强督汤) prescribed.     

IMPROVING P-gp EXPRESSION IN HUMAN MONONUCLEAR CELLS IN VITRO TRANSFECTED BY MULTIDRUG RESISTANCE-1 mRNA

CHEMOTHERAPY playsa greatrolein the treat- ment of malignanttumors,especiallyingynecolo- gicalones.But inanticancerchemotherapy,leuko-cytopeniaisfrequentlytheprimarydose-limitingsideeffect factor.Moreover,cancersarefrequentlychemoresistantbe-causeof overexpressionof P-glycoprotein(P-gp), which isencodedby multidrugresistancegene (MDR1 ) and detectableinup to50% ofhuman cancersand renderscellsresistancetoanticancerdrugs.The safetyand potentialtherapeuticbenefitof mdr1 gene transferredto h…