Preparation of multicore millimeter-sized spherical alginate capsules to specifically and sustainedly release fish oil

Specific and sustained release of nutrients from capsules to the gastrointestinal tract has attracted many attentions in the field of food and drug delivery.In this work,we reported a monoaxial dispersion electrospraying-ionotropic gelation technique to prepare multicore millimeter-sized spherical capsules for specific and sustained release of fish oil.The spherical capsules had diameters from 2.05 mm to 0.35 mm with the increased applied voltages.The capsules consisted of uniform(at applied voltages of≤10 k V)or nonuniform(at applied voltages of>10 k V)multicores.The obtained capsules had reasonable loading ratios(9.7%-6.3%)due to the multicore structure.In addition,the obtained capsules had specific and sustained release behaviors of fish oil into the small intestinal phase of in vitro gastrointestinal tract and small intestinal tract models.The simple monoaxial dispersion electrospraying-ionotropic gelatin technique does not involve complicated preparation formulations and polymer modification,which makes the technique has a potential application prospect for the fish oil preparations and the encapsulation of functional active substances in the field of food and drug industries.

Effect of rhBMP-2 sustained-release nanocapsules on the ectopic osteogenesis process in Sprague-Dawley rats

Objective:To explore the effect of sustained-release recombinant human bone morphogenetic protein-2(rhBMP-2) on ectopic osteogenesis in the muscle pouches of rats through preparing rhBMP-2 sustained-release capsules by wrapping morphogenesis protein bones-2(BMP-2)using chitosan nanoparticles,and compositing collagen materials.Methods:Twenty four SpragueDawley rats were randomly divided into four groups with six rats in each group,that is Group A(control group),Group B(only treated with collagen),Group C(rhBMP-2+collagen treated group) and Group D(rhBMP-2/cs+collagen treated group).The composite materials for each group were implanted in the bilateral peroneal muscle pouches in rats.The peroneal muscles were only separated without implanting any materials in control group.Rats were sacrificed 2 weeks and 4 weeks post treatment and samples were cut off for general observation,Micro CT scans and histological observation.Results:General observation showed no new bone formation in Groups A and B mice,while new bones were formed in Groups C and D mice.Two weeks after treatment Micro CT scans showed that The bone volume fraction(BVF),trabecular thickness(Tb. Th),bone mineral density(BMD) in Group C mice were all higher than that in Group D(P<0.05). At the fourth week,the BVK,Tb.Th and BMD were significantly higher than that at the second week(P<0.01).Conclusions:The slow-release effect of rhBMP-2/cs sustained-release capsules can significantly promote ectopic osteogenesis.Its bone formation effect is better than that of rhBMP-2 burst-release group.

Preparation and bioavailability in healthy volunteers of cefaclor modified-release capsules

Aim To investigate whether modified-release cefaclor capsules could lead to a more suitable pharmacokinetic profile in the plasma. Methods Cefaclor pellets were prepared by extrusion/spheronization and coated by Eudragit L30D-55 or Eudragit NE30D, then the two sorts of pellets were filled to capsules in a 35：65 ratio to made a modified-release （MR） capsules. The bioavailability of the MR capsules was studied in 24 healthy volunteers after oral administration in a fast state using a commercially available immediate release （IR） capsule as a reference. Results The results showed that the MR formulation had a relatively good bioavailability compared with the commercial capsules, as well as a longer time keeping drug level above MIC than immediate release capsule. The relative bioavailability of the MR capsules was 97.4- 12.1%. Conclusion The data of the present study indicate that time of cefaclor plasma concentration above MIC can be substantially prolonged if cefaclor is administered as a modified- release product.

Pharmacokinetic Study on Lovastatin Sustained-release Tablet and Sustained-release Capsule in Begal Dogs

This study pharmacokinetically examined the lovastatin sustained-release tablet and sustained-release capsule in Beagle dogs. An reversed-phase HPLC method was established for the determination of lovastatin in Beagle dog plasma. Pharmacokinetic findings were compared among three preparation(lovastatin sustained-release tablet,T p; sustained-release capsule,T J and conventional capsule). Our results showed that the pharmacokinetic parameters in 6 dogs after single-dose oral administration of three perparations were calculated. T max, C max and MRT revealed significant difference (P<0.05). Relative bioavailability was 111.5±16.9 % (T P) and 110.4%±9.6 % (T J). The pharmacokinetic parameters in the 6 dogs after multiple-dose oral administration of three perparations, T max, C max MRT and DF had significant difference (P<0.05); C av , C min and AUC 0-24 h displayed no significant difference (P>0.05). It is concluded that the lovastatin sustained-release tablet and sustained-release capsule are able to maintain a sustained-release for 24 h.

4D printing of core-shell hydrogel capsules for smart controlled drug release

Personalized drugs,as well as disease-specific and condition-dependent drug release,have been highly desired in drug delivery systems for effective and safe therapies.Four-dimensional(4 D)printing,as a newly emerging technique to develop drug capsules,displays unique advantages that can autonomously control drug release according to the actual physiological circumstances.Herein,core-shell structured hydrogel capsules were developed using a multimaterial extrusion-based 4 D printing method,which consists of a model drug as the core and UV cross-linked poly(N-isopropylacrylamide)(PNIPAM)hydrogel as the shell.Owing to the lower critical solution temperature(LCST)-induced shrinking/swelling properties,the prepared PNIPAM hydrogel capsules showed temperature-responsive drug release along with the topography changes in the cross-linked PNIPAM network.The in vitro drug release test confirmed that the PNIPAM hydrogel capsules can autonomously control their drug release behaviors according to changes in ambient temperature.Moreover,the increased shell thickness of these capsules causes an obvious reduction in drug release rate,distinctly indicating that the drug release behavior can be well adjusted by setting the shell thickness of the capsules.The proposed 4 D printing strategy pioneers the paradigm of smart drug release by showing great potential in the smart controlled release of drugs and macromolecular active agents.

Polymeric Hydrogel Nanocapsules: A Thermo and pH Dual-responsive Carrier for Sustained Drug Release

Hydrogel capsules show attractive prospects in drug delivery recently because of high drug loading and sustained release behavior. In this study we reported a simple and convenient route to fabricate poly(acrylic acid)-poly(N-isopropylacrylamide)(PAA-PNIPAm) hydrogel capsules by using hydroxypropylcellulose-poly(acrylic acid)(HPC-PAA) complexes as the templates. The capsules showed a high drug loading(～280% to the weight of capsules) for Doxorubicin hydrochloride. The release of drug from the capsules was responsive to the temperature and p H of the surroundings, showing a low-rate but sustained release behavior favorable for low-toxic and long-term therapy. Together with the convenient preparation, high drug loading, dual responsivity as well as the sustained release feature, it is implied that this polymeric hydrogel capsule might be a promising candidate for new drug carriers.

Arthroscopic Capsular Release for Frozen Shoulder—Time to Thaw the Delay?

Introduction: Frozen shoulder is a common condition that affects the working population. Current management regimes are variable nationwide and the evidence base on which to base these decisions is poor. The longevity and severity of symptoms often result in great economic burden, both to health services and in terms of absence from work. Early surgical intervention with arthroscopic capsular release may result in improved symptoms and earlier return to both work and leisure activities. Aims: The aim of our prospective cohort study was to investigate whether early intervention with arthroscopic capsular release resulted in improvement of symptoms and whether this would in turn provide overall economic benefit to society. Methods: Patients diagnosed with frozen shoulder at an elective orthopaedic specialist shoulder clinic were recruited prospectively. Data were gathered by way of questionnaire to ascertain the demographic information of the patient as well as their previous treatment in the primary care setting and absence from work. Initial Oxford Shoulder Score (OSS) was also calculated: Arthroscopic capsular release was then performed and further data gathered at four-week post-operative follow-up. Economic impact of delay to treatment and cost of intervention were calculated using government data from the national tariff which cost different forms of treatment. Statistical analysis was then performed on the results. Results: Twenty five patients were recruited. Mean results were: Age of patients: 53.5 years, duration of symptoms prior to intervention: 35.2 weeks, days absent from work: 31.5, number of previous physiotherapy sessions: 7.2, number of steroid injections: 1.3. Mean pre-operative OSS was 37.4 (range 27 - 58, SD 7.4). Mean post-operative OSS was 15.9 (range 12 - 22, SD 2.3), P 0.01. Mean improvement in OSS was 21.5 (range 12 - 38, SD 7.1). The cost of non-operative treatment per patient including absence from work to the point of surgical intervention was ￡3954. The overall cost of arthroscopic capsular release per patient was ￡1861, a difference of ￡2093. There were no surgical complications. Conclusion: Arthroscopic capsular release improved shoulder function on OSS within four weeks. This is significantly shorter than the natural history of frozen shoulder. The overall cost of arthroscopic capsular release is significantly less than the cost of treating the patients non-operatively up to the point of surgical intervention. Early surgical intervention may improve symptoms quickly and reduce economic burden of the disease. A randomised controlled trial comparing early with late intervention would further elucidate potential benefits.

Arthroscopic capsular release and manipulation under anaesthesia for frozen shoulders:A hot topic

A frozen shoulder is a common cause of shoulder pain and stiffness.The etiology and pathology of frozen shoulders is not fully understood yet.Frozen shoulderis characterized by a decrease in intra-articular volume and capsular compliance.This can lead to significant limitations in daily life.The majority of the patients can be treated conservatively,with functional recovery to be expected in two to three years.However,if conservative treatment fails,manipulation under anaesthesia and arthroscopic capsular release can both be considered as appropriate treatments.Manipulation is a traditionally well-established technique but in recent years it seems that arthroscopic capsular release has gained popularity.Manipulation is a relative time efficient and technically low-demanding procedure in which the glenohumeral joint is forced into different directions under general anaesthesia to release the capsular contracture,thereby increasing the range of motion of the joint.In arthroscopic capsular release the glenohumeral capsule can be released in a more controlled manner under direct vision.There are no prospective comparative trials available to display superiority of one procedure over the other.In addition,the optimal timing of both these interventions still has to be determined.An overview of the literature concerning this topic and a description of both procedures with its own advantages and disadvantages is provided.

布地奈德缓释胶囊治疗免疫球蛋白A肾病的研究进展

免疫球蛋白A肾病是一种常见的自身免疫性肾病。越来越多的研究表明,免疫球蛋白A肾病可能与黏膜免疫系统功能障碍有关。免疫球蛋白A肾病是以半乳糖缺陷型IgA1免疫复合物的系膜沉积为特征,这种半乳糖缺陷型IgA1被认为起源于黏膜上的B细胞,而B细胞大量存在于富含派尔集合淋巴结的远端回肠中。布地奈德新型靶向释放制剂已被证明可以将药物输送到远端回肠,目的是将免疫球蛋白A肾病患者的不良事件降至最低。本文对布地奈德缓释胶囊的作用机制、剂型特点、临床研究、药物相互作用和不良事件以及局限性等进行综述。

胶囊聚合物驱提高采收率方法

针对常规聚合物驱剪切易降解、注入困难等难题,提出了胶囊聚合物驱提高采收率方法,采用多尺度渗流实验及模拟技术分析了胶囊聚合物驱渗流机制与驱油机理。研究表明:胶囊聚合物驱具有易注入、抗剪切、地层可控释放、吸附滞留率小的优势,具有很好的远距离运移能力,可实现聚合物驱“油藏深部增黏”;胶囊聚合物增黏程度越高,抑制黏性指进的能力越强,驱替前缘越趋于均匀,驱替波及范围越大。胶囊聚合物的释放性能主要受温度影响,温度越高,胶囊聚合物溶液增黏速度越快,而矿化度对胶囊聚合物溶液增黏速度的影响很小。胶囊聚合物驱适用于传统聚合物驱效果不佳的高含水油藏、井距较大的海上聚合物驱油藏、常规聚合物注入性较差的中低渗透油藏等。实施胶囊聚合物驱应“因地制宜”,根据目标油藏条件设计合理的胶囊粒径、释放时间以达到最优的驱油效果。

他克莫司常释与缓释胶囊预防肝移植术后排斥反应成本-效果分析

目的评价他克莫司常释胶囊与缓释胶囊预防肝移植术后排斥反应的成本-效果。方法选取首都医科大学附属北京友谊医院肝移植门诊2016年1月1日至2023年6月30日收治的肝移植术后患者1520例。其中,1031例患者术后口服常释胶囊,489例患者口服缓释胶囊,并在此基础上加用吗替麦考酚酯胶囊(用法用量相同)行免疫抑制治疗。利用TreeAge Pro 2021软件构建Markov模型,研究时限设为30年。以我国医疗卫生体系视角收集成本(直接医疗成本)及效果参数,对缓释胶囊和常释胶囊预防肝移植术后排斥反应的成本-效果进行分析,并通过单因素敏感性分析和概率敏感性分析验证模型。结果与常释胶囊比较,缓释胶囊的增量成本-效果比(ICER)为159357.86元/质量调整生命年(QALY),小于意愿支付阈值(25.7094万元)。缓释胶囊的价格、贴现率和常释胶囊的价格对模型结果影响较大。肝移植术后30年,缓释胶囊具有成本-效果的概率为63.72%。结论肝移植术后30年时限内,与常释胶囊比较,缓释胶囊预防肝移植术后排斥反应更有药物经济学优势。

红金消结胶囊联合醋酸亮丙瑞林治疗子宫内膜异位症临床研究

目的:观察红金消结胶囊联合醋酸亮丙瑞林治疗子宫内膜异位症的临床疗效。方法:选取82例子宫内膜异位症患者,按随机数字表法分为对照组与治疗组各41例。对照组给予注射用醋酸亮丙瑞林缓释微球治疗,治疗组在对照组基础上联合红金消结胶囊联合治疗。比较2组临床疗效与不良反应发生率,以及2组治疗前后中医证候评分、血清糖类抗原125 (CA125)、抗子宫内膜抗体(EMAb)、脂联素(APN)、肝细胞生长因子(HGF)水平、子宫体积、子宫内膜厚度、包块直径。结果:治疗组总有效率为95.12%,对照组为78.05%,2组比较,差异有统计学意义(P<0.05)。治疗后,2组中医证候评分均较治疗前降低(P<0.05),且治疗组中医证候评分低于对照组(P<0.05)。治疗后,2组子宫内膜厚度、子宫体积、包块直径均较治疗前缩小(P<0.05),且治疗组上述3项指标均小于对照组(P<0.05)。治疗后,2组血清CA125、EMAb、HGF水平均较治疗前降低(P<0.05),APN水平较治疗前升高(P<0.05);且治疗组CA125、EMAb、HGF水平低于对照组(P<0.05),APN水平高于对照组(P<0.05)。对照组不良反应发生率为9.76%,治疗组为4.88%,2组比较,差异无统计学意义(P>0.05)。结论:红金消结胶囊联合注射用醋酸亮丙瑞林缓释微球治疗子宫内膜异位症疗效显著,能改善患者临床症状和体征,调节相关血清细胞因子水平,且没有增加药物治疗的不良反应。

15个厂家布洛芬缓释胶囊仿制药与参比制剂溶出曲线的比较

目的通过比较15个厂家生产的布洛芬缓释胶囊与参比制剂的体外溶出曲线,为其质量一致性评价提供参考。方法以pH1.0盐酸溶液、pH4.0醋酸盐缓冲液、pH6.0磷酸盐缓冲液和pH7.2磷酸盐缓冲液分别作为溶出介质,体积为900 ml,采用篮法,转速为30 r/min,进行释放度考察,采用高效液相色谱(HPLC)法测定布洛芬的含量,并计算累积溶出量,绘制溶出曲线,采用差异因子(f_(1))和相似因子(f_(2))法评价溶出曲线的相似性。结果厂家A在pH1.0盐酸溶液和pH4.0醋酸盐缓冲液介质中,与参比制剂相比,f_(1)>15,溶出曲线有差异。其他14个厂家与参比制剂在4种溶出介质中,f_(1)均<15且f_(2)均>50,溶出曲线相似,溶出行为一致。结论厂家A仿制制剂与原研地产化参比制剂在非药典溶出度检查项目规定的溶出介质中存在溶出行为不完全一致的情况,可能与其处方及生产工艺有关,仍需结合具体的生物等效性试验以及其他药学指标进行一致性的全面评估。

夏荔芪胶囊联合坦索罗辛治疗前列腺增生症临床疗效观察

目的:观察中药夏荔芪胶囊联合盐酸坦索罗辛缓释胶囊治疗前列腺增生症患者的临床疗效。方法:选取2021年5月8日-2022年11月30日于天津医科大学第二医院收治的前列腺增生患者76例,随机分为试验组和对照组:试验组口服夏荔芪胶囊(1.35 g,3次/d)联合盐酸坦索罗辛缓释胶囊(0.2 mg,每晚睡前服用);对照组仅口服盐酸坦索罗辛缓释胶囊(0.2mg,每晚睡前);两组患者均治疗8周后,比较两组治疗前后国际前列腺症状评分(I-PSS)、中医证候评分、最大尿流率(Qmax)、前列腺体积、残余尿量、NIH-CPSI评分及生活质量评分(QOL),比较两组用药方案的有效性和安全性。结果:治疗后,两组的IPSS评分和中医证候评分与治疗前比较均明显降低(P<0.05),试验组治疗后I-PSS和中医症候评分均小于对照组(P<0.05),其中试验组中医证候评分降低幅度显著大于对照组(P<0.001);治疗后试验组与对照组的前列腺体积、残余尿量及QOL均无统计学差异(P>0.05)。试验组治疗后Qmax大于对照组(P=0.007),且试验组增大幅度显著大于对照组(P<0.001),试验组治疗后NIH-CPSI小于对照组(P=0.044),且试验组治疗前后NIH-CPSI差值大于对照组(P=0.008)。试验组总体有效率达94.7%,大于对照组的42.1%,差异有统计学意义(P<0.001)。结论:夏荔芪胶囊联合盐酸坦索罗辛缓释胶囊治疗良性前列腺增生症的有效性显著高于对照组,且在治疗过程中两组患者均未发生不良事件,安全性与依从性好。

改性的玉米醇溶蛋白植物胶囊的制备研究

目的:以玉米醇溶蛋白为原料与阿拉伯胶复合,制成具有缓释作用的植物胶囊。方法:玉米醇溶蛋白与阿拉伯胶进行复合工艺研究,以紫外图谱和粘度值为指标,采用红外光谱和差示扫描量热仪进行检验;以玉米醇溶蛋白膜的水蒸气透过系数和透油性为指标,得到性能最优的配方制成植物胶囊,并进行贮存稳定性试验;以吲哚美辛为模型药物,填充于玉米醇溶蛋白植物胶囊中,磷酸盐缓冲液作为溶出介质,进行植物胶囊缓释性能的研究。结果:确定复合工艺固液比为10∶1.3,pH为6,红外光谱和差示扫描量热仪检验的结果表明形成了复合物。通过单因素实验确定最佳配方条件为:冰醋酸体积分数75%、羧甲基纤维素钠添加量0.2g、聚乙烯吡咯烷酮添加量0.4 g,将复合物0.2 g添加到上述条件中,制成植物胶囊,可使成囊率达到95%。结论:测定药物的释放度符合药典规定,说明植物胶囊具有缓释性能。

参松养心胶囊联合美托洛尔缓释片治疗老年冠心病心律失常患者的临床效果

目的研究参松养心胶囊联合美托洛尔缓释片治疗老年冠心病心律失常患者的临床效果。方法回顾性选取2020年6月至2021年6月我院收治的96例老年冠心病心律失常患者作为研究对象,依据治疗方法不同将其分为联合治疗组(美托洛尔缓释片联合参松养心胶囊治疗)和单独治疗组(美托洛尔缓释片治疗),各48例。比较两组的治疗效果。结果联合治疗组的治疗总有效率高于单独治疗组(P<0.05)。治疗后,联合治疗组的心功能分级优于单独治疗组(P<0.05)。治疗后,联合治疗组的心排出量、心脏指数、射血分数均高于单独治疗组(P<0.05)。联合治疗组的室性期前收缩、房性期前收缩、交界性期前收缩、短阵心房颤动发生次数均少于单独治疗组(P<0.05)。治疗后,联合治疗组的缺血发生次数、缺血总负荷低于单独治疗组,缺血持续时间短于单独治疗组(P<0.05)。联合治疗组的不良反应总发生率低于单独治疗组(P<0.05)。结论参松养心胶囊联合美托洛尔缓释片治疗老年冠心病心律失常效果显著,可减少其心律失常发作频率,改善心功能。

冠心苏合胶囊联合硝苯地平控释片治疗不稳定型心绞痛的临床效果研究

目的 探讨冠心苏合胶囊联合硝苯地平控释片治疗不稳定型心绞痛(UAP)的临床效果。方法 将2021年5月到2023年5月在黑龙江省第二医院接受治疗的104例UAP患者按随机数字表法分为观察组(52例)和对照组(52例)。对照组口服硝苯地平控释片进行治疗,观察组口服冠心苏合胶囊以及硝苯地平控释片进行治疗。在治疗30 d后进行疗效评价,比较2组患者治疗前后的血清炎症因子和血液流变学指标,比较2组患者的不良反应发生情况。结果 观察组总有效率高于对照组[94.2%(49/52)比80.8%(42/52)],差异有统计学意义(P=0.038)。治疗30 d后,2组患者血清基质金属蛋白酶9、白细胞介素18、C反应蛋白水平均明显低于治疗前,且观察组均低于对照组(均P<0.05)。治疗30 d后,2组患者纤维蛋白原、低切全血黏度、中切全血黏度、高切全血黏度、血浆黏度均明显低于治疗前,且观察组均低于对照组(均P<0.05)。对照组不良反应发生率与观察组比较[5.8%(3/52)比9.6%(5/52)],差异无统计学意义(P=0.713)。结论 冠心苏合胶囊联合硝苯地平控释片治疗UAP具有较好的临床效果,可有效改善患者的炎症状态和血液高凝状态,且安全性较好。

高效液相色谱测定布洛芬药物制剂含量方法的优化

通过优化色谱条件,建立专属性良好的高效液相色谱测定多种布洛芬药物制剂中布洛芬含量。采用Dikma Silversil C18键合硅胶色谱柱(250 mm×4.6 mm,5μm)为分析柱,柱温为30℃,以乙腈-磷酸溶液(体积比为80∶20)作为流动相,流量为1.0 mL/min,进样体积为10µL,以光电二极管阵列检测器检测,检测波长为263 nm。采用色谱峰面积外标法测定布洛芬缓释胶囊、原料药和颗粒剂中布洛芬的含量。布洛芬质量浓度在0.0916~1.099 mg/mL范围内与色谱峰面积线性关系良好,相关系数为0.9997,检出限为3.68μg/mL。布洛芬缓释胶囊、原料药和颗粒剂的样品加标平均回收率分别为99.73%~102.00%、99.45%和101.80%,测定结果的相对标准偏差分别为0.27%~1.18%、1.97%和1.99%(n=6)。优化后的高效液相色谱法准确可靠,适用于多种布洛芬药物制剂中布洛芬的含量测定,可以为多种布洛芬药物制剂的质量评价和质量控制提供参考和方法选择依据。

左炔诺孕酮宫内缓释节育系统治疗围绝经期妇女异常子宫出血的效果

目的:观察围绝经期妇女异常子宫出血应用左炔诺孕酮宫内缓释节育系统治疗的临床效果。方法:选取2020年8月—2022年8月滕州市工人医院收治的80例围绝经期异常子宫出血患者作为研究对象,随机分为两组,各40例。两组均进行诊断性刮宫治疗,对照组给予宫血宁胶囊,研究组给予左炔诺孕酮宫内缓释节育系统。比较两组治疗效果、临床指标及激素水平。结果:研究组治疗总有效率高于对照组,差异有统计学意义(P=0.043)。治疗后,两组经期时长短于治疗前,且研究组短于对照组,子宫内膜厚度小于治疗前,且研究组小于对照组,月经量少于治疗前,且研究组少于对照组,差异有统计学意义(P<0.05)。治疗后,两组卵泡刺激素、雌二醇、孕酮水平低于治疗前,且研究组低于对照组,两组黄体生成素水平高于治疗前,且研究组高于对照组,差异有统计学意义(P<0.05)。结论:左炔诺孕酮宫内缓释节育系统治疗围绝经期妇女异常子宫出血的效果显著,可改善患者临床症状,调节激素水平。

单硝酸异山梨酯缓释胶囊治疗冠心病、心绞痛临床综合评价

目的评价单硝酸异山梨酯缓释胶囊治疗冠心病、心绞痛的临床综合价值,以期为临床合理用药和政府决策提供参考。方法根据《药品临床综合评价管理指南(2021版试行)》和《心血管病药品临床综合评价技术指南(2022年版试行)》相关要求,主要运用文献研究法和专家咨询法对单硝酸异山梨酯缓释胶囊的安全性、有效性、经济性、适宜性、创新性和可及性6个维度进行综合评估。结果安全性方面,相关文献和说明书均表明头痛为缓释胶囊最主要的不良反应,且缓释胶囊和缓释片之间的安全性无统计学差异。有效性方面,使用单硝酸异山梨酯缓释胶囊对冠心病、心绞痛进行干预有显著效果,且与单硝酸异山梨酯缓释片有效性相当。经济性方面,无论是进行最小成本分析和成本⁃效果分析,研究品均具有一定的经济性。创新性方面,缓释胶囊在维持血药浓度和保证产品质量稳定方面有创新。适宜性方面,缓释胶囊与缓释片均具有良好的技术特点适宜性和使用适宜性。可及性方面,患者使用缓释胶囊的经济负担较低,且相关中选企业能有效保障缓释胶囊的供应和价格的稳定。结论单硝酸异山梨酯缓释胶囊在六个维度均具有良好的表现,其临床综合价值与单硝酸异山梨酯缓释片相当。