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1.
Three factors, three levels (33) full factorial design was used to develop venlafaxine HCl fast dissolving oral films (FDOFs) to optimize the concentrations of the film forming polymer; hydroxypropyl methylcellulose HPMC (X1), superdisintegrant; sodium starch glycolate SSG, (X2) and glycerol as the film plasticizer (X3). Effects of the three factors on the disintegration time (Y1), swelling index (Y2), and dissolution efficiency at 15 min; DE%15 (Y3) of the prepared FDOFs were evaluated by using statistical models. The optimized film formula was characterized in term of x-ray powder diffraction (XRPD), differential scanning calorimetry (DSC) and morphological characteristics.Disintegration time was found to increase with the increase in HPMC (X1) concentration, and the shortest disintegration time (21.67 ± 2.08 s) was observed in case of F2 formula (lowest HPMC level and highest glycerol level in absence of SSG). The highest swelling index (3.64 ± 0.59) was observed in case of film formula F1 (medium concentrations of both HPMC and glycerol and highest SSG concentration. The results also indicated that as the concentration of HPMC increased the DE%15 decreased. SSG (X2), with highest value (72.33 ± 1.71%) was recorded for in case of F12 (using 2% HPMC, 5%SSG and 1.5% glycerol). The optimized FDOF formula derived by the statistical models suggested 2% HPMC, 5% SSG, and 1% glycerol.The data obtained from DSC and XRPD revealed no interaction between drug and FDOT excipients. In addition, XRPD studies proved that the venlafaxine HCl was homogeneously dispersed in the film matrix.  相似文献   
2.
张嫒  谷福根 《中国药师》2016,(11):2035-2038
摘 要 目的:测定盐酸文拉法辛(Ven)的表观油水分配系数(P)及其水溶液的化学稳定性,为今后研制Ven的黏膜吸收给药液体制剂奠定基础。方法: 采用HPLC法测定Ven的浓度;测定Ven在正辛醇 水/pH 2~10磷酸缓冲液系统中的P值;测定Ven在pH 2~12磷酸缓冲液以及不同离子强度条件下的降解百分率。结果: Ven在正辛醇 水系统中的P值为0.16;在正辛醇 pH 2~10缓冲液系统中,当pH≤6.0时,Ven的P值接近于1,当pH>6.0时,随着pH的增加,药物的P值显著增大。Ven溶液在pH≤8.0时,其化学稳定性良好,在碱性pH下,化学稳定性较差;离子强度对Ven溶液的化学稳定性无影响。结论:Ven的油水分配系数及溶液的化学稳定性与pH密切相关。在pH约为7.0时,Ven具有较高油水分配系数及化学稳定性。  相似文献   
3.
目的:探讨文拉法辛联合胰岛素泵治疗伴焦虑抑郁2型糖尿病的临床疗效及安全性。方法:将确诊为2型糖尿病患者伴焦虑抑郁患者59例随机分为两组,均采用胰岛素泵治疗2周,之后改为优泌乐25皮下注射,治疗组同时口服文拉法辛,观察8周;治疗前后分别作 SAS、SDS、皮质醇( CRO)、白细胞介素-6( L-6),超敏C-反应蛋白( hsC-RP )比较,观察血糖达标时间及胰岛素用量情况,观察治疗后两组不良反应。结果:治疗前两组SAS、SDS评分均明显高于国内常模( P<0.01),治疗后治疗组SAS、SDS、CRO、L-6、hsC-RP 较治疗前有统计学意义(P<0.05),但对照组较治疗前无显著性差异( P>0.05);治疗组血糖达标时间及胰岛素用量均明显少于对照组,差异有统计学意义( P<0.05);两组不良反应发生率不高,均为轻度,能耐受。结论:文拉法辛联合胰岛素泵治疗伴焦虑、抑郁的2型糖尿病起效快,效果肯定,不良反应少,值得推广使用。  相似文献   
4.
IntroductionDepression is considered a syndrome with a constellation of symptoms that are frequently categorized into 3 domains including affective, somatic and cognitive. There has been limited research into the domain specific magnitude or relative timing of treatment response in patients with Parkinson's disease (PD). In addition, antidepressant trials involving patients with PD have demonstrated a similar robust placebo response to that seen in other populations. However, the timing of the placebo response has not been carefully studied.MethodsWe studied differential responses to antidepressant treatment in affective, somatic and cognitive domains of depression. Patients were treated for twelve weeks with placebo, venlafaxine or paroxetine as part of the Study of Antidepressants in Parkinson's Disease (SAD-PD) randomized controlled trial. Depressive symptoms were evaluated with three commonly used rating scales.ResultsAll symptom domains improved during the study period, There was a significant placebo effect, especially in the first two weeks that had diminished by week 12. Compared to placebo, the affective symptoms significantly improved during treatment as early as week 4, followed by the somatic symptoms of depression in week 6 and cognitive symptoms in week 8. The largest response was seen in the affective domain.ConclusionIn depressed PD patients treated with venlafaxine or paroxetine, affective symptoms improved first, followed by somatic symptoms and cognitive symptoms. These findings could guide patient counselling and increase patient compliance by informing about the expected treatment responses. The substantial placebo effect underlines the importance of a sufficiently long study period in future studies.  相似文献   
5.
目的:应用事件相关电位(ERP)听觉P300(即P3)评估盐酸文拉法辛缓释片对Ⅱ型精神分裂症患者认知功能的影响。方法:选取疗效已达显著进步以上的Ⅱ型精神分裂症患者42例,随机分为研究组(22例)和对照组(20例)。研究组给予盐酸文拉法辛缓释片治疗,在治疗前后对两组患者分别进行听觉ERP检查及阳性症状与阴性症状量表(PANss)评定。结果:在治疗后,研究组靶刺激P300潜伏期缩短(P〈0.05)和波幅升高(P〈0.05),PANSS评定提示阴性因子分、反应缺乏因子分及抑郁因子分下降和激活因子分升高(P〈0.05),与对照组比较,差异有统计学意义(P〈0.05)。对照组在治疗前后P300各项目和PANSS评分比较差异无统计学意义(P〉0.05)。结论:从ERP的P300可反映出盐酸文拉法辛缓释片能改善U型精神分裂症患者的认知功能。  相似文献   
6.
目的 研究盐酸文拉法辛缓释片在Beagle犬体内的药动学和生物等效性。方法 8条健康Beagle犬随机分成2组,采用双周期、双交叉、单剂量分别ig盐酸文拉法辛缓释片受试制剂或参比制剂75 mg,清洗期为1周;建立血浆中盐酸文拉法辛液相色谱-质谱联用(LC-MS/MS)检测方法,进行方法精密度、准确度、提取回收率、基质效应、稳定性方法学验证;测定给药前(0 h)及给药后2、3、4、5、6、8、10、12、14、16、24、36、48、72 h血浆中盐酸文拉法辛血药浓度,运用DAS 2.1.1软件计算其药动学参数,并评价其生物等效性。结果 LC-MS/MS方法学经验证符合检测要求,受试制剂和参比制剂主要药动学参数分别如下:T1/2分别为(7.16±2.34)和(6.95±1.57) h、Cmax分别为(522.89±201.12)和(515.22±159.29)ng/mL、Tmax分别为(10.38±1.69)和(10.50±2.07)h、AUC0-t分别为(8 398.64±3332.86)和(8 050.71±2103.15)ng·h/mL、AUC0-∞分别为(8 701.60±3303.29)和(8 450.01±2273.45)ng·h/mL;以参比制剂为参考,受试制剂AUC0-∞相对生物利用度为(101.0±13.1)%。结论 盐酸文拉法辛缓释片受试制剂与参比制剂在Beagle犬体内具有生物等效性。  相似文献   
7.
摘 要 目的: 评价度洛西汀和文拉法辛治疗抑郁症的疗效与安全性。方法: 计算机检索PubMed、CNKI、VIP、万方数据库等文献数据库,以及手工检索相关文献,采用RevMan5.3进行Meta分析。结果: 纳入研究12项,共872例患者,Meta分析显示:在痊愈率(RR=0.99, 95%CI:0.78~1.27)和有效率(RR=1.01, 95%CI:0.91~1.13)方面,度洛西汀组(治疗组)和文拉法辛组(对照组)的差异无统计学意义(P>0.05);治疗组和对照组的不良反应分析(RR合并=1.05, 95%CI:0.86~1.28)显示,两组的差异无统计学意义(P>0.05)。但是通过亚组分析显示,消化系统(RR=1.43, 95%CI:1.11~1.84)和心血管系统(RR=0.41, 95%CI:0.21~0.79)方面的不良反应发生率的差异有统计学意义(P<0.05),治疗组胃肠道反应比对照组多,心血管方面不良反应较对照组少。结论:度洛西汀和文拉法辛治疗抑郁症疗效相当,不良反应也无明显差异,但是在临床使用中对于有消化系统疾病或心血管系统疾病的患者,在药物选择时应有所区别,以减少不良反应风险,提高治疗效率。  相似文献   
8.
Background: Venlafaxine use to achieve an amphetamine-like high has been described but data regarding the epidemiology and clinical effects are sparse. Objectives: Describe the prevalence and toxicity of venlafaxine abuse reported to US poison control centers. Methods: This was a retrospective review of venlafaxine exposures reported to the National Poison Data System (NPDS) from 2000 to 2016. Inclusion criteria were: age 12 years and older, reason for exposure intentional-abuse, and either single-substance exposure or venlafaxine was the first substance. The primary outcome was prevalence of intentional-abuse of venlafaxine. Secondary outcomes characterized demographics, geographic distribution, toxicity, and outcomes. Results: Intentional-abuse accounted for 752 of 85,621 venlafaxine exposures. Overall prevalence was 87.8 intentional-abuse exposures/10,000 venlafaxine exposures reported to NPDS (range, 59.3–117.6/10,000). Prevalence decreased from 107/10,000 in 2000 to 59.3/10,000 in 2016. Median age was 23 years and 50% were female. Primary route was ingestion (90.8%) with 4.7% using venlafaxine via inhalation/intranasal insufflation, and 3.7% both routes. There were 227 venlafaxine-only exposures; 54.0% were treated/released from the emergency department, 20% were admitted for medical management, 9.0% to a psychiatric facility, and 17.0% managed at home. Known medical outcomes for single-substance exposures were: no effect (24.0%), minor (39.0%), moderate (33.0%), and major (4.0%); no deaths occurred. Most frequent clinical effects were tachycardia (33.9%), drowsiness (20.7%), and agitation (11.5%). Conclusion: The prevalence of venlafaxine abuse reported to poison control centers has decreased. Medical outcomes are usually not serious. Clinicians should be aware that non-medical use is possible but infrequently reported to poison control centers.  相似文献   
9.
目的探讨药物基因检测下使用文拉法辛治疗抑郁症的效果和安全性,为个体化用药提供参考。方法纳入符合《国际疾病分类(第10版)》(ICD-10)抑郁发作诊断标准的66例患者为研究对象。将药物基因检测报告建议并选用文拉法辛治疗的患者分为研究组(n=32),医生与患者协商后决定使用文拉法辛治疗的患者为对照组(n=34)。于治疗前及治疗2、4、6、8周末使用汉密尔顿抑郁量表24项版(HAMD-24)评定临床疗效,于治疗前及治疗8周末使用席汉残疾量表(SDS)评定患者的社会功能,于治疗后采用副反应量表(TESS)评定不良反应发生情况。结果治疗4、6、8周末,研究组HAMD-24评分均低于对照组,差异均有统计学意义(t=2.344、4.316、5.760,P0.05或0.01);治疗8周末,研究组SDS评分低于对照组,差异有统计学意义(t=2.173,P0.05),研究组不良反应发生率低于对照组,差异有统计学意义(χ~2=5.720,P0.05)。结论基于药物基因检测使用文拉法辛治疗抑郁症,可能有助于改善患者的抑郁情绪,且安全性更好。  相似文献   
10.
Tricyclic antidepressants (TCA) are well-known xerogenic drugs, while antidepressants such as selective serotonin reuptake inhibitors (SSRI) are considered less xerogenic. The antimuscarinic effect of the TCAs has been considered to be the principal mechanism causing a dry mouth. Although the muscarinic receptor is commonly targeted by xerogenic pharmaceuticals, the salivation reflex arc may be affected at other levels as well. We currently wondered whether or not antidepressants exert an inhibition of the salivary reflex not only at the glandular level but at a central level as well. In this study, the effects of a TCA (clomipramine), a SSRI (citalopram) and a serotonin-noradrenaline reuptake inhibitor (SNRI; venlafaxine) were examined on reflex- (0.5 M citric acid applied on the tongue) and methacholine-evoked salivary secretion. While all three compounds inhibited citric acid-evoked secretion (−40 to −60% at 5 mg/kg i.v. of the antidepressants), only clomipramine inhibited methacholine-evoked secretion (−30% at 5 mg/kg i.v.). On the contrary, both citalopram and venlafaxine increased the methacholine-evoked secretion (+44 to 49%). This was particularly obvious for the salivary protein output (>200%). In the presence of α- and β-adrenoceptor antagonists, the citalopram- and venlafaxine-induced increases were reduced. Thus, antidepressants irrespective of type may exert xerogenic effects by inhibiting the salivary reflex in the central nervous system. However, while TCAs may also hamper the secretory response by antimuscarinic effects, the SSRI and the SNRI groups of pharmaceuticals seem to lack this additional xerogenic mechanism indicating a better therapeutic profile and better opportunities for pharmacological treatment of drug-induced xerostomia.  相似文献   
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