目的：考察硝苯地平缓释片的释放度（I）控制情况。方法：通过不同厂家、不同处方工艺的硝苯地平缓释片（I）和不同仪器的释放度检测结果，反映硝苯地平缓释片（I）释放度的差异性。结果与结论：硝苯地平缓释片释放度检测结果符合质量标准要求，但制剂批的质量一致性有待提高，明确需进行工艺或质量检测方法研究，进行体内外溶出相关性的评价工作。

Objective:Study extended release Nifedipine tablets release control. Methods:Extended Release Nifedipine Tablets(I) detection results of release by different manufacturers, different formulation and different instruments, reflect the Extended Release Nifedipine Tablets (I) status release. Results and Conclusion:Extended Release Nifedipine Tablets release test results meet the quality standards, but the quality consistency preparation batch should be improved, need to study the detecting method of process or quality, expansion in vitro and in vivo evaluation of the relationship between work stripping.

目的：评价单用硝苯地平治疗单纯收缩期高血压（ ISH）的有效性和安全性。方法计算机检索Cochrane Library（2013年第5期），PubMed、EMbase、CBM、EMCC、CNKI、VIP和WanFang Data等数据库，检索时限从1996年1月至2013年6月。文献的质量评价按照Cochrane系统评价手册进行，使用RevMan 5.0软件进行系统评价。结果最终纳入6篇随机对照试验进行分析，合计695例患者。Meta分析结果显示：①降压有效率：硝苯地平缓释片较复方降压片高，差异有统计学意义[RD=0.26，95%CI（0.11，0.40），P ＜0.05]，其余各组差异无统计学意义。②不良反应/事件发生率：硝苯地平片与尼莫地平片[RD=0.02，95%CI（-0.16，-0.19），P =0.83]，硝苯地平控释片与苯磺酸氨氯地平片[RD=0.05，95%CI（-0.01，0.10），P =0.12]，硝苯地平缓释片与复方降压片[RD=-0.10，95%CI（-0.24，0.04），P =0.18]比较，差异无统计学意义。结论本系统评价显示治疗ISH疗效：①硝苯地平缓释片强于复方降压片；②硝苯地平控释片与苯磺酸氨氯地平片相似，但弱于吲达帕胺片；③硝苯地平片与尼莫地平片相似。单用硝苯地平治疗ISH的不良反应可以接受。

Objective To evaluate the efficacy and safety of nifedipine in treatment of patients with isolated systolic hypertension( ISH). Methods The data were collected from PUBMED,EMBASE,EMCC,SINOMED,CNKI,VIP and Wanfang database during January 1996 to June 2013. The quality of included studies was critically evaluated. Data analyses were performed with the Cochrane Collaborations RevMan 5. 0 software. Results Six randomized control trials( RCTs)met the inclusion criteria,altogether 695 patients had been included in this study. Meta-analyses showed that the effective rate in patients receiving nifedipine group was higher than that of fufangjiangyapian group(RD 0. 26,95%CI 0. 11 to 0. 40,P <0. 05),while no significant difference had been noticed among other control groups. The incidence of adverse effects was not significantly higher in nifedipine group compared to that of nimodipine group(RD 0. 02,95%CI -0. 16 to -0. 19,P =0. 83),nifedipine con-trolled release tablet group compared t

目的：探讨硝苯地平缓释片联用厄贝沙坦氢氯噻嗪治疗高血压病的临床疗效。方法：采取随机双盲对照法,将80例高血压病患者随机分为两组,治疗组患者口服硝苯地平缓释片20mg/次,每12h 一次,厄贝沙坦氢氯噻嗪150mg,1次/ d,疗程为20周；对照组患者只口服硝苯地平缓释片,剂量方法同治疗组,同时控制每日摄入热量。观察两组患者治疗前后血压情况。结果：治疗组患者总有效率90%,对照组患者总有效率25%,经统计学处理有显著差异（P〈0.05）。结论：硝苯地平缓释片与厄贝沙坦氢氯噻嗪联合用药可提高血压控制率。

Objective:To explore the clinical effect of Irbesartan and Hydrochlorothiazide combined Nifedipine sustained re-lease tablets on hypertension. Methods:According to a randomized, double blind controlled method, all 80 patients with primary hy-pertension were divided into treatment group and control group. The control group was given Nifedipine sustained - release tablets (20mg, oral treatment, one time/ 12 hours) and energy restriction, while the observation group was given Irbesartan and Hydrochlo-rothiazide (150 mg, oral treatment, once a day for 20 weeks) on the basis of that of the control group, but without energy restriction. The blood pressure was compared before and after the treatment. Results: The efficiency of observation group (90% ) was significantly higher than that of control group (25% ), and there was a significant statistical difference between the two groups (P<0. 05). Conclu-sions: Irbesartan and Hydrochlorothiazide combined Nifedipine sustained release tablets can r

目的分析硝苯地平缓释片联合吲达帕胺片对原发性高血压患者血压和肾功能的影响。方法随机将117例原发性高血压患者进行分组,对照组予硝苯地平缓释片,实验组予硝苯地平缓释片联合吲达帕胺片,3个月后观察综合疗效、血压水平变化、肾功能指标和药物不良反应。结果实验组总有效率91.53%高于对照组75.86%,差异有统计学意义(P0.05);实验组对血压和肾功能影响幅度小于对照组(P0.01);实验组不良反应发生率10.17%与对照组8.62%比较,差异无统计学意义(P0.05)。结论硝苯地平缓释片联合吲达帕胺片降低原发性高血压的血压和控制血压水平效果确切,能够增加肾脏血流量以降低肾脏损害,安全可靠。

Objective To analyze the influence of nifedipine extended release tablets combined with indapamide tablets on the blood pressure and renal function of patients with primary hypertension. Methods A total of 117 patients with primary hypertension were randomly divided into two groups. The control group was given nifedipine extended release tablets and the experimental group was given nifedipine extended release tablets combined with indapamide tablets. Three months later, the comprehensive efficacy, blood pressure changes, renal function indicators and adverse drug re-actions of the two groups were compared. Results The total effective rate of the experimental group was 91.53%, which was higher than the 75.86% of the control group, with statistically significant difference (P 0.05). Conclusion In the treatment of primary hypertension, nifedipine extended release tablets combined with indapamide tablets shows accurate efficacy in reducing and controlling blood pressure, can increase re-na

研究羟丙甲纤维素的不同关键材料属性(CMAs)的样品(QbD样品)对以难溶性药物硝苯地平(溶解度11μg/ml)为模型药物的亲水凝胶骨架缓释片的药物释放的影响。方法:采用直接压片的方式,分别使用粘度、粒度和羟丙基含量等属性分别接近标准上下限范围的羟丙甲纤维素QbD样品和其他辅料一起制成硝苯地平骨架缓释片,并按标准规定的方法对体外释放曲线进行测定。结论:在标准规定范围内羟丙甲纤维素的粘度、粒度和羟丙基含量的波动对硝苯地平亲水凝胶骨架缓释片的释放没有显著的影响。

Objective:The objective of this study was to study the influence of different critical quality attribute samples of hypro-mellose (QbD sample) on hydrophilic extended release matrix tablets of water insoluble drug nifedipine (solubility in water, 11μg/ml) as model drug. Methods:The nifedipine extended release matrix tablets were manufactured by direct compression (DC) method with hypromellose QbD sample and other excipients, which critical material attributes (CMAs) of viscosity, particle size and hydroxypropox-yl content close to the range of limitation. The in-vitro drug release profiles from extended release hydrophilic matrix tablets were test-ed according to the method of criteria. Conclusion:The variation of viscosity, particle size, and hydroxylpropoxyl content of hyprom-ellose within the limit has no significant influence on drug release profile of nifedipine extended release matrix tablets.