Absorption of different oral dosage forms of oxycodone in the elderly: a cross-over clinical trial in patients undergoing cystoscopy

Purpose

To characterize the pharmacokinetics (PK) of oxycodone following intravenous injection and administration of three oral dosage forms (solution, capsule, and controlled-release tablet) in elderly patients (age 76–89?years) undergoing cystoscopy.

Methods

This was an open, randomized study with two sequences and two visits in 15 elderly patients. The patients were given intravenous injection (over 10?min) of 5?mg of oxycodone hydrochloride trihydrate. Oxycodone hydrochloride (5?mg in all forms) was orally administered as a solution, a capsule, and a controlled-release tablet. Venous blood samples were collected up to 17?h after oxycodone administration. Population PK parameters were calculated with NONMEM VI 2.0. For intravenous injection we calculated clearance, volume of distribution at steady state, and the half-life of elimination, and for oral dosage forms also the absolute bioavailability.

Results

Clearance of the intravenous injections was 28.9?L/h; the volume of distribution at steady state and the half-life of elimination were 186?L and 5.2?h, respectively. The absolute bioavailability of oxycodone was 59?% from oral solutions, 64?% from capsules, and 55?% from controlled-release tablets.

Conclusions

Our results indicate that, in the elderly, the bioavailability of the three different oral dosage forms of oxycodone is fairly similar.     

塞来昔布联合曲马多在膝关节表面置换术超前镇痛的疗效观察

目的：观察塞来昔布联合曲马多对膝关节表面置换术的超前镇痛疗效。方法将行膝关节表面置换术的90例随机分为A、B、C三组,术前2 d至禁食前分别口服盐酸曲马多缓释片50 mg、塞来昔布胶囊200 mg、塞来昔布胶囊100 mg＋盐酸曲马多缓释片25 mg,术后6 h分别口服盐酸曲马多缓释片50 mg、塞来昔布胶囊200 mg、塞来昔布胶囊100 mg＋盐酸曲马多缓释片25 mg,术后2 d分别口服盐酸曲马多缓释片50 mg/12 h、塞来昔布胶囊200 mg q12 h、塞来昔布胶囊100 mg＋盐酸曲马多缓释片25 mg/12 h;三组患者均于术后麻醉消失后行硬膜外镇痛（PCEA）,观察比较三组患者术后8 h、24 h、36 h、48 h静息状态下疼痛和术后3晚睡眠的视觉模拟评分法（ VAS）评分、PCEA首次按压时间及术后48 h内按压次数、患者疼痛满意度、药物不良反应。结果 C组患者镇痛疗效、睡眠质量、疼痛满意度均显著优于A组、B组（P＜0．05）,C组显著地提升镇痛效果。三组术后不良反应未见显著差异（P＞0．05）。结论围术期联合应用塞来昔布和曲马多可有效实现膝关节表面置换术的超前镇痛。     

The role of sevelamer in achieving the kidney disease outcomes quality initiative (K/DOQI) guidelines for hyperphosphatemia

BACKGROUND: End-stage renal disease (ESRD) is a chronic health care problem associated with multiple co-morbidities and escalating costs. Disregulation of mineral metabolism (principally hyperphosphatemia and hypercalcemia) contributes to substantial morbidity and mortality. Accordingly, new and more-aggressive Kidney Disease Outcomes Quality Initiative (K/DOQI) Guidelines from the National Kidney Foundation promote lower serum phosphorus (3.5-5.5 mg/dL), lower calcium (8.4-9.5 mg/dL), and lower calcium-phosphorus product (< 55 mg(2)/dL(2)) targets. REVIEW FINDINGS: Traditional calcium-based and metal-based phosphate binders are effective but are associated with side effects and toxicity that limit their use. Achieving rigorous K/DOQI goals demands higher therapeutic doses of phosphate binders and may require more-aggressive use of calcium-free and metal-free phosphate binders. Sevelamer hydrochloride is a calcium- and metal-free polymer that binds phosphate effectively without contributing to calcium load or metal accumulation. In the Treat-to-Goal trial, sevelamer-treated dialysis patients had less progression of coronary and aortic calcification than patients treated with calcium-based binders. This offers the potential promise of reducing cardiovascular morbidity and mortality. The 800-mg tablet (Renagel) increases the daily sevelamer dose while reducing the number of tablets required per meal. Nine of the 800-mg tablets per day (3 x 800-mg tablets tid with meals) of sevelamer monotherapy have been shown to achieve K/DOQI serum phosphorus and calcium-phosphorus product targets. CONCLUSION: In summary, this review of the current evidence-base concludes that the new, more-aggressive, K/DOQI goals limit the use of metal-based and calcium-based phosphate binders. Sevelamer offers the advantages of lowering serum phosphorus without the risks of calcium or metal accumulation - and offers the promise of slowing the progression of vascular calcification and potentially reducing the morbidity and mortality of hemodialysis patients.     

我院口服固体药品外观标识调查分析

目的：对我院使用的口服固体药品外观标识的现状进行调研,为减少用药差错、保证用药安全提供依据。方法：将我院住院药房中口服固体药品除去外包装,对每种药品外观标识（包括颜色、形状、表面标识等）进行描述分析,并测量片剂最大直径。结果：48种胶囊剂中有27种无表面标识;278种片剂以白色为主,占片剂总数的65．11％,无表面标识的药片占片剂总数的48．56％,形状以圆形为主,占片剂总数的75．54％,药片直径范围在4．0～21．0mm之间。结论：药品生产厂家应加强口服固体药品外观标识的可识别性,建议建立统一标准和药品编码识别系统。     

Continuous dissolution rate determination as a function of the pH of the medium.

A method was developed for varying the pH of the medium during dissolution rate studies of timed-release tablets with the aid of compressed, totally soluble, alkaline powder mixtures. Commercial as well as experimental timed-release capsules or tablets were used as models, and dissolution rates were determined at pH 1.1, 2.4, and 7.4. The system can be applied to other pH values or other variations of the dissolution medium (e.g., ionic strength) to: (a) correlate in vitro release rates with bioavailability data, (b) discriminate between alternative formulations during dosage form development, or (c) serve as a selective control procedure for a series of sustanined-release dosage forms.     

Evaluation of xanthan and highly substituted galactomannan from M. scabrella as a sustained release matrix

A highly substituted galactomannan (G) from Mimosa scabrella Bentham (Man:Gal 1.1:1), isolated from the seeds of a Brazilian leguminous tree and xanthan (X), an exopolysaccharide secreted by Xanthomonas campestris (Keltrol), were evaluated as a hydrophilic matrix system (XG) for controlled release (CR) of diclofenac sodium (DS) in tablets and capsules. The performance of XG (2:1) matrices containing 50 mg (A) or 100 mg (B) of DS was compared with a commercial CR product of DS. The drug release studies were carried out using a dissolution apparatus (paddle method) with gradual increase of pH values, from pH 1.4, to pH 4.0 (after 1 h) and to pH 6.8 (after 2 h). The results suggested the potential of XG systems as release retarding materials, which released 78.6 and 35.1% of drug after 24 h for capsules (A) and tablets (A), respectively. Drug release decreased with the increase of amount of drug and it is dependent of dosage form. Analysis of release data indicate a rather zero-order drug release with the erosion mechanism playing a dominant role.     

RP-HPLC测定盐酸二甲双胍肠溶片的含量

目的：依《中国药典》所述盐酸二甲双胍肠溶胶囊含量测定的方法,对盐酸二甲双胍肠溶片含量测定方法进行研究。方法：采用C18（4.6 mm＆#215;250 mm,5μm）色谱柱,流动相为0.05%庚烷磺酸钠溶液（用10%的磷酸溶液调节pH值至4.0）-乙腈（84∶16）,柱温：30℃,检测波长232 nm。结果：盐酸二甲双胍在2.335～37.36μg/mL范围内线性关系良好,r=0.9999,平均回收率为100.34%（n=9）。结论：药典所述肠溶胶囊的含量测定方法简便准确,灵敏度高,专属性好,不仅能够用于肠溶胶囊的测定,同时也能够用于盐酸二甲双胍肠溶片的质量控制。     

Relief of postpartum uterine cramping with propoxyphene and aspirin

Two propoxyphene salts, the hydrochloride and the napsylate, were administered in equimolar quantities as capsules to women professing postpartum uterine cramping. The doses used were 65 and 130 mg of the hydrochloride and 100 and 200 mg of the napsylate. Enteric-coated aspirin tablets, in doses of 325 and 650 mg, were also included in the study, as were identical-appearing placebo capsules and tablets. Single oral doses consisting of 1 capsule and 2 tablets were given with the double-blind control so that equal numbers of patients were treated with each of the 15 medication combinations. Responses in proportion to the dose followed the administration of propoxyphene and of aspirin. Large doses of both analgesics in combination were associated with responses less than expected from the sums of the responses to these same doses given separately. This phenomenon may result from a plateau effect associated with maximum response. A relationship between dosage and possible side effects was not demonstrated.     

对某国产盐酸二甲双胍肠溶胶囊溶出度的评价研究

目的：评价盐酸二甲双胍肠溶胶囊在不同p H条件下的溶出曲线。方法：参照2010版《中华人民共和国药典》附录X B、XD,采用桨法考察盐酸二甲双胍肠溶胶囊在pH分别为1.0、4.0、纯水条件下2h后调节为pH6.8磷酸缓冲液再溶出1h的溶出性能, HPLC法测定溶出液中二甲双胍浓度,DDSolver 1.0对溶出曲线进行分析。结果：盐酸二甲双胍肠溶胶囊在pH1.0、pH4.0及纯水2h内几乎不释放,而在pH6.8的磷酸盐缓冲液中45min内释放达90%以上。经软件DDSolver1.0分析3种pH条件下的溶出曲线是相似的。结论：该二甲双胍肠溶胶囊在不同pH条件下的溶出曲线是相似的,对于不同患者溶出性能一致,药品品质较佳。     

非诺贝特咀嚼片治疗高脂血症的疗效观察

目的观察非诺贝特咀嚼片治疗高脂血症的有效性和安全性。方法在北京五所医院选择血浆甘油三酯水平≥2．26mmol／L的患者100例,按随机号分为咀嚼片组和胶囊组2组,分别给予非诺贝特咀嚼片及非诺贝特胶囊200mg／d,共治疗8周。治疗前后测定血脂及安全参数并进行分析,记录药物不良反应情况。结果与治疗前比,治疗8周后2组患者的甘油三酯水平均有显著的下降,高密度脂蛋白胆固醇水平明显升高。咀嚼片组与胶囊组降低甘油三酯及升高高密度脂蛋白胆固醇效果相似,差异无统计学意义（分别为44．88％与45．11％及16．51％与13．35％,P〉0．05）,2组总体疗效接近（84．1％与86．7％,P〉0．05）。结论非诺贝特咀嚼片降低甘油三酯及升高高密度脂蛋白胆固醇效果理想,安全性较好。     

盐酸二甲双胍格列吡嗪胶囊的健康人体药动学研究

目的:评价健康受试者口服复方制剂盐酸二甲双胍格列吡嗪胶囊(每粒含盐酸二甲双胍250 mg,格列吡嗪2.5 mg)的人体血浆药代动力学特征,为临床用药提供参考依据。方法:20名健康受试者随机分为2组,每组10人(男女各半)。Ⅰ组不同周期先后单剂量口服低剂量(1粒)和高剂量(3粒)试验制剂;Ⅱ组不同周期先后三交叉单剂量口服中剂量(2粒)试验制剂、格列吡嗪片(2.5 mg.片-1)参比制剂2片、盐酸二甲双胍胶囊(250 mg.粒-1)参比制剂2粒,并进行了中剂量试验制剂的多剂量试验。采集受试者的血浆样本,分别采用HPLC-UV法测定血浆中盐酸二甲双胍的浓度,HPLC-MS/MS法测定血浆中格列吡嗪的浓度。DAS 2.0软件计算主要药代动力学参数,并进行统计分析,确定复方用药时盐酸二甲双胍与格列吡嗪是否存在药代动力学相互作用。结果:受试者单剂量服用低、中、高剂量,及多剂量服用中剂量试验制剂达稳态后,血浆中盐酸二甲双胍的Cmax分别为(718±122),(1179±308),(1494±174),(979±268)ng.mL-1;Tmax分别为(1.7±0.63),(3.4±0.94),(2.4±0.70),(3.9±1.4)h;AUC0-t分别(4519±606),(8646±2757),(10040±1501),(8965±2200)ng.h.mL-1;t1/2分别为(3.46±0.34),(4.74±0.80),(4.90±1.42),(4.99±0.58)h;格列吡嗪的Cmax分别为(294±63.4),(432±98.7),(641±76.5),(273±51.5)ng.mL-1;Tmax分别为(1.8±0.54),(1.9±0.78),(1.9±0.47),(4.0±2.0)h;AUC0-t分别为(1642±340),(2788±994),(3508±758),(2841±1003)ng.h.mL-1;t1/2分别为(4.04±0.53),(4.70±0.75),(3.88±0.77),(6.46±5.83)h。单剂量口服盐酸二甲双胍胶囊(500 mg)的Cmax、Tmax、AUC0-t、t1/2分别为:(1179±308)ng.mL-1,(3.35±0.94)h,(8646±2757)ng.h.mL-1,(4.74±0.80)h;单剂量口服格列吡嗪片(5 mg)的Cmax、Tmax、AUC0-t、t1/2分别为:(485±88.9)ng.mL-1,(1.28±0.38)h,(2860±462)ng.h.mL-1,(4.38±0.89)h。单剂量与多剂量口服中剂量试验制剂时,测得盐酸二甲双胍和格列吡嗪的主要药代动力学参数分别均无显著性差异。与单剂量口服相应剂量的格列吡嗪片或盐酸二甲双胍胶囊后的主要药代动力学参数比较,也分别无显著性差异。单剂量服用低、中、高剂量试验制剂后,盐酸二甲双胍和格列吡嗪的Cmax与AUC0-t均随剂量正比例增大。结论:盐酸二甲双胍和格列吡嗪复方给药具有线性药动学特征,均没有积蓄效应,盐酸二甲双胍和格列吡嗪复方给药没有明显的药物相互作用。     

Determination of 4-aminophenol impurities in multicomponent analgesic preparations by HPLC with amperometric detection

A method for the determination of 4-aminophenol, the main impurity of paracetamol, by high-performance liquid chromatographic (HPLC) method with amperometric detection has been developed. The analysis was performed in an isocratic mode on a reversed phase Luna column 5 microm C-18 (100 x 4.6 mm). A mobile phase (0.05 mol l(-1) LiCl solution containing 18% methanol adjusted to pH 4.0 with orthophosphoric acid) was suitable for the separation and determination of 4-APh. Chromatograms were recorded for 250 s by means of an amperometric detector at a potential of +325 mV of the glassy carbon electrode versus the reference electrode Ag/AgCl. The proposed liquid chromatographic method was successfully applied to the analysis of commercially available multicomponent dosage forms. The sensitivity of the detection for 4-aminophenol was 1 ng ml(-1) for substance and 4 ng ml(-1) for tablets or capsules. The method developed in this study is sensitive and selective and can be applied for routine studies of pharmaceuticals in the form of tablets or capsules.     

2006-2007年我院门诊吗啡控缓释片利用分析

目的：了解和评估我院门诊吗啡控缓释片的应用情况。方法：对2006-2007年我院门诊吗啡控缓释片处方共3 007张进行整理统计,并对用药频度（DDDs）、药物利用指数（DUI）、剂量、给药间隔和给药途径的利用情况进行分析。结果：（1）2006年和2007年我院门诊吗啡控缓释片共有4个制剂,分别是盐酸吗啡缓释片（10mg、30mg）和硫酸吗啡控释片（10mg、30mg）,其DUI值介于1.46-2.89之间,硫酸吗啡控释片（30mg）的两个年度DDDs值分别为15887、21256,明显大于其他3个制剂;（2）按季度统计,盐酸吗啡缓释片10mg和硫酸吗啡控释片30mg两个制剂的消耗量呈微幅上升趋势;（3）两年中按给药剂量分类统计,每次给药30mg以下和大于150mg的消耗量各约占总消耗量的1/4,而每次给药30mg以下的实际用药总天数（AUD）占总AUD的64.3%;（4）按给药间隔分类统计,给药间隔为12h的消耗量占88.5%,而给药间隔为6h的占0.6%,但未写明给药间隔的占0.2%;（5）按给药途径统计消耗量,共有口服和直肠给药两种,后者约占1%。结论：2006-2007我院门诊吗啡控缓释片的利用总体合理,但也存在部分处方书写及用法不合理的情况。     

不同固体剂型盐酸伐昔洛韦制剂的溶出度考查

目的：比较4个不同厂家固体制剂盐酸伐昔洛韦片剂和胶囊的溶出度,为临床用药提供参考。方法：采用紫外分光光度法测定盐酸伐昔洛韦含量,转篮法测定溶出度,并以威布尔分布模型拟合溶出参数,再对T50,Td,m进行统计分析。结果：4个厂家不同固体剂型中盐酸伐昔洛韦片剂和胶囊剂的溶出度均符合2005年版《中国药典》规定,其T50、Td、m值两两间均存在显著性差（P（0.05）。结论：该方法操作简便、准确,可用于该药溶出度的测定。     

The role of sevelamer in achieving the kidney disease outcomes quality initiative (K/DOQI) guidelines for hyperphosphatemia

SUMMARY

Background: End-stage renal disease (ESRD) is a chronic health care problem associated with multiple co-morbidities and escalating costs. Disregulation of mineral metabolism (principally hyperphosphatemia and hypercalcemia) contributes to substantial morbidity and mortality. Accordingly, new and more-aggressive Kidney Disease Outcomes Quality Initiative (K/DOQI) Guidelines from the National Kidney Foundation promote lower serum phosphorus (3.5–5.5?mg/dL), lower calcium (8.4–9.5?mg/dL), and lower calcium-phosphorus product (< 55?mg²/dL²) targets.

Review findings: Traditional calcium-based and metal-based phosphate binders are effective but are associated with side effects and toxicity that limit their use. Achieving rigorous K/DOQI goals demands higher therapeutic doses of phosphate binders and may require more-aggressive use of calcium-free and metal-free phosphate binders. Sevelamer hydrochloride is a calcium- and metal-free polymer that binds phosphate effectively without contributing to calcium load or metal accumulation. In the Treat-to-Goal trial, sevelamer-treated dialysis patients had less progression of coronary and aortic calcification than patients treated with calcium-based binders. This offers the potential promise of reducing cardiovascular morbidity and mortality. The 800-mg tablet (Renagel*) increases the daily sevelamer dose while reducing the number of tablets required per meal. Nine of the 800-mg tablets per day (3 × 800-mg tablets tid with meals) of sevelamer monotherapy have been shown to achieve K/DOQI serum phosphorus and calcium-phosphorus product targets.

Conclusion: In summary, this review of the current evidence-base concludes that the new, more-aggressive, K/DOQI goals limit the use of metal-based and calcium-based phosphate binders. Sevelamer offers the advantages of lowering serum phosphorus without the risks of calcium or metal accumulation – and offers the promise of slowing the progression of vascular calcification and potentially reducing the morbidity and mortality of hemodialysis patients.     

Absorption characteristics of a new valproate formulation: divalproex sodium-coated particles in capsules (Depakote Sprinkle)

To determine the absorption characteristics of a new dosage form of divalproex sodium consisting of coated particles in a pull-apart capsule (Depakote Sprinkle, Abbott Laboratories, North Chicago, IL), two absorption studies were conducted in adult volunteers. Ten fasting men participated in a single-dose, crossover study comparing absorption from Sprinkle capsules versus enteric-coated tablets (study 1). Eleven men participated in a multidose study (study 2) in which Sprinkle capsules or enteric-coated tablets were given once every 24 hours for three doses under fasting and nonfasting conditions. In study 1, the extent of absorption from Sprinkle capsules equalled that from enteric-coated tablets. Compared to enteric-coated tablets, Sprinkle capsules had earlier absorption onset, 1 versus 2.6 hours (P less than .05), slightly slower absorption rate, time to reach peak (tmax) of 4.0 versus 3.4 hours (P less than .1), and lower maximum peak plasma drug concentration (Cmax), 20.7 versus 25.9 mcg/mL (P less than .05). In study 2, food intake did not affect onset or extent of absorption nor maximum concentration, but did slow rate of absorption. Time to reach peak concentration was 2.7 hours for tablet (fasting), 3.3 hours for capsule (fasting), and 4.8 hours for capsule (nonfasting) (P less than .05). Intrasubject absorption performance from the three doses was highly consistent, regardless of food intake. These data indicate that Sprinkle capsules possess desirable absorption characteristics in a form that makes ingestion easier for patients who have difficulty taking other valproate dosage forms.     

Spectrophotometric and spectrofluorimetric methods for the determination of ropinirole content in pharmaceutical dosage forms

Two simple and rapid spectrofluorimetric and spectrophotometric methods were described for the determination of ropinirole hydrochloride content in pharmaceutical dosage forms. Both methods are based on the reaction of ropinirole hydrochloride and eosin Y in aqueous medium at pH 4.0. Quenching of the fluorescence intensity of eosin Y at 540 nm upon excitation at 350 nm was used for the determination of ropinirole hydrochloride levels after ion-pair complex formation. Also, the absorbance increase of eosin Y at 546 nm after ion-pair complex formation was used for spectrophotometric measurements. Both methods showed linear relationships between the fluorescence quenching or absorbance increase and ropinirole concentration in the range of 6–150 µg/mL and 50–500 µg/mL for spectrofluorimetric and spectrophotometric methods, respectively. As no organic solvents were used in these two methods, they could be categorized as green analytical methods. Both methods were accurate (Error<1.2%) and precise (CV<1.9%), as shown by statistical analysis results. Both methods were used for determination of ropinirole hydrochloride content in pharmaceutical dosage forms without any significant interference from associated impurities.     

Pharmacokinetics of papaverine hydrochloride and the biopharmaceutics of its oral dosage forms

The pharmacokinetics of completely metabolized papaverine hydrochloride were characterized by a linear sum of three exponentials on intravenous administration with respective 1.5, 19 and 107 min apparent half lives. There was a time-dependent partition from plasma water into red blood cells with an apparent half life of 1.5--3 min. The partition coefficient normally ranged between 8 and 15 at therapeutic levels but approached unity at high plasma concentrations to indicate a saturable partition. Apparent compartmental volumes of distribution referenced to total concentrations in the plasma were 4.3--4.8, 11--13 and 20--25 liters. Protein binding was 91--95%. The hepatic clearance of blood was 960 ml/min, corresponding to a hepatic efficiency of 69%, and indicated that the clearance of protein-bound drug was consistent with the observed first pass metabolism of 70% for oral solutions. No dose dependency was observed on intravenous administration or on oral administration of solutions and tablets. Tablets with release lag times of 10--15 min showed relative bioavailabilities of 52%. Two different lots of sustained release capsules showed 68 and 89% relative bioavailabilities. Release lag times among capsules ranged between 0 and 170 min. Loo-Riegelman calculations and analog computer fittings were consistent with a half life of absorption from oral solutions of 19 min and zero order release rates from tablets and sustained release capsules. Chronic studies of tablets q.i.d. and capsules b.i.d. confirmed lack of accumulation. An appropriately designed 300 mg sustained release capsule, b.i.d., for an arbitrary plasma level of 0.200 microgram/ml should have one tenth the release rate of the studied capsules.     

不同厂家盐酸地芬尼多片溶出曲线相似性考察

目的：考察8个厂家盐酸地芬尼多片在不同溶出介质中的溶出曲线,比较不同厂家药品内在品质,为药品质量控制提供参考.方法：采用高效液相色谱法测定8个厂家盐酸地芬尼多片在水、pH1.2、pH4.0和pH6.8四种介质中的溶出曲线,结合AV值对溶出曲线得相似性进行比较分析.结果：在pH1.2、pH4.0和水三种溶出介质中各厂家盐酸地芬尼多片溶出量均符合药典规定,但溶出曲线差异性较大;在pH6.8中溶出量偏低.结论：仅1家企业4条溶出曲线均与原研厂家标准溶出曲线相似,企业仍需进一步改进处方及生产工艺以提高产品质量.     

盐酸雷尼替丁胶囊人体药动学和生物等效性研究

目的:评价国产盐酸雷尼替丁胶囊与进口盐酸雷尼替丁片的人体生物等效性。方法:采用反相高效液相色谱法,测定20名健康志愿者随机分组、自身对照单次口服盐酸雷尼替丁胶囊或盐酸雷尼替丁片300mg后不同时刻的血药浓度,计算药动学参数,并进行方差分析和双单侧t检验。结果:盐酸雷尼替丁片与盐酸雷尼替丁胶囊的Cmax分别为(1247.1±547.5)、(1294.8±613.2)μg/L;tmax分别为(2.98±0.73)、(2.73±0.80)h;t1/2分别为(3.17±0.36)、(3.33±0.42)h;AUC0～t分别为(5805.9±1403.5)、(5941.2±1526.3)(μg·h)/L;AUC0～∞分别为(6163.8±1456.4)、(6351.8±1652.7)(μg·h)/L;盐酸雷尼替丁胶囊相对于盐酸雷尼替丁片的生物利用度为(104.3±24.3)%。结论:2种制剂具有生物等效性。