HPLC测定人体血浆中替硝唑浓度

目的:建立替硝唑血药浓度测定方法,用于复方替硝唑片血药浓度研究。方法:采用高效液相色谱法。色谱柱为C18柱,流动相为12%乙腈水溶液(pH7.0),检测波长318nm。结果:样品组分在0.2～20μg.ml-1线性良好(r=0.9998),最低血浆药物检测浓度为0.02μg.ml-1。回收率为94.4%～98.3%,日内及日间RSD<5%。结论:本法简便、迅速、灵敏、准确,适合于临床药学研究需要。     

复方双黄连分散片的质量标准研究

目的建立复方双黄连分散片（金银花、黄芩、连翘、蒲公英等）的质量标准。方法采用TLC法对蒲公英、黄芩苷和绿原酸进行鉴别。用HPLC法测定黄芩苷的含量。结果TLC鉴别方法专属性强。黄芩苷在1．6μg～4．0μg范围内呈良好的线性关系，r=0．9998，加样回收率为99．69％，RSD为0．4％。含量限度黄芩苷为不少于80mg／片。本方法操作简单，结果准确，灵敏度高，重复性好。结论本质量标准可有效地控制复方双黄连分散片的质量。     

二陈分散片的研制及质量控制

目的:制备二陈分散片并建立其质量控制方法。方法:采用交联羧甲基纤维素钠为崩解剂,加入聚乙烯吡咯烷酮等辅料制备分散片;采用高效液相色谱法测定制剂中橙皮苷含量,并进行成品稳定性考察。结果:橙皮苷进样量在1μg～80μg范围内线性关系良好,平均回收率为99.98%,RSD=0.98%;制剂稳定性良好。结论:该制剂处方合理,制备工艺简单,成品符合《中国药典》各项质量指标要求。     

不同厂家生产的盐酸曲马多缓释片整片与半片的三维释放特性考察

目的:对不同厂家(A、B、C)的盐酸曲马多缓释片的整片与半片进行pH-时间-释放度考察,探讨整片与半片体外释放机制的差异.方法:转篮法,用紫外分光光度法检测,描绘其三维释放图像,将释放数据用相似因子法、Peppas方程进行分析.结果:在同一pH条件下,A、C的整片与半片释放曲线不相似,释放机制也不相同;B的整片与半片释放曲线相似,释放机制相同.结论:不同厂家盐酸曲马多缓释片整片与半片的体外释放不尽相同.     

复方杜仲片质量标准研究

目的完善复方杜仲片的质量标准.方法对方中的牛膝、益母草进行TLC鉴别,对黄芩采用HPLC法定量,色谱条件为Kromasil-C18柱,以甲醇-水-磷酸(45:55:0.2)为流动相;检测波长为315 nm;流速1.0 mL·min-1.结果在选定的薄层条件下,牛膝、益母草的薄层图谱清晰,分离度好.黄芩苷在0.537 66～2.688μg范围内具有良好的线性关系,其回归方程为:A=39 094.51 C-800.14,r=0.999 9.平均回收率为96.5%,RSD=2.1%.结论实验方法操作简单,可以用来控制本制剂质量.     

反相高效液相色谱法测定风湿骨康片中士的宁的含量

目的:建立RP-HPLC法测定风湿骨康片中士的宁的含量,完善质量标准.方法:采用Hyper-C18柱,0.03mol·L-1甲酸溶液(用三乙胺调节pH至3.0±0.1)-乙腈(78∶22)为流动相,254nm为检测波长.结果:测得线性范围0.416μg～4.992μg(r=0.9998),平均回收率98.65%,RSD为1.88%(n=5).结论:本法简便,准确,专属性强.     

甲磺酸加替沙星片治疗急性细菌性感染的细菌学疗效

目的评价甲磺酸加替沙星片治疗急性细菌性感染疾病的细菌学疗效. 方法以盐酸左氧氟沙星片为对照药,采用多中心随机盲法阳性对照平行试验设计方法,评价甲磺酸加替沙星片治疗急性细菌性感染的细菌学疗效. 结果甲磺酸加替沙星片组和盐酸左氧氟沙星片组细菌分离阳性率分别为77.42%和80.99%;两组细菌清除率分别为 97.92%和97.96%;对不同致病菌感染有效率分别为83.33%～100%和80%～100%;以上结果两组差异无统计学意义;纸片药敏试验结果表明加替沙星、左氧氟沙星、氧氟沙星、环丙沙星和司帕沙星的细菌敏感率分别为93.81%、93.30%、91.24%、84.54%和87.11%;从MIC90结果看,加替沙星对多数致病菌的抗菌活性略强于左氧氟沙星. 结论甲磺酸加替沙星片具有良好的细菌学疗效.     

健胃愈疡片联合三联疗法治疗反流性食管炎

【摘要】 目的 探讨健胃愈疡片联合三联疗法治疗反流性食管炎的临床疗效。方法 选择2015年2月~2017年2月我院接诊的90例反流性食管炎患者,通过随机数表法分为观察组和对照组各45例,在基础治疗上,对照组给予三联疗法（奥美拉唑+甲硝唑+阿莫西林）治疗,观察组联合健胃愈疡片治疗,两组均连续治疗4周。比较两组治疗前后血清胃泌素（GAS）、一氧化氮（NO）、生长激素释放多肽（Ghrelin）、瘦素（Leptin）和中医证候积分的变化,并比较治疗后粘膜愈合率及临床疗效。结果 治疗后,两组血清GAS、Ghrelin较治疗前均显著升高,血清NO、Leptin显著降低（P＜005）,观察组血清GAS、Ghrelin明显高于对照组,血清NO、Leptin明显比对照组低（P＜005）;治疗后,两组烧心、反酸、胸痛症状积分较治疗前均显著降低（P＜005）,观察组烧心、反酸、胸痛症状积分均明显比对照组低（P＜005）;观察组粘膜愈合率明显高于对照组（P＜005）;观察组临床总有效率明显高于对照组（P＜005）。结论 健胃愈疡片联合三联疗法治疗反流性食管炎效果显著,可有效促进食管粘膜愈合、缓解临床症状,促进临床疗效提高,可在临床推广应用。     

Assessing compressibility and compactibility of powder formulations with Near-Infrared Spectroscopy

Context: The compressibility and compatibility of a powder formulation is usually determined by compaction and following destructive tensile strength and relative density measurement of the final compact.

Objective: In this study, a non-destructive method with Near-Infrared Spectroscopy (NIRS) was designed and evaluated for the measurement of powder compressibility and compactibility.

Materials and Methods: 12 different formulations with a wide range of difference in properties were investigated by compaction and analysis of the resulting tablets. Two similar tablet batches were produced with every formulation. Relative density and tensile strength were measured with the traditional, destructive method on one tablet batch while a newly developed non-destructive chemometric NIRS method was applied for the second batch. The outcomes of the two approaches were compared to validate the developed method. All data sets were applied to three established mathematical equations to calculate equation factors, which are claimed to represent the formulation compressibility and compactibility. The study focus was set on the equation factor value comparison between the traditional and the newly designed method.

Results & Discussion: The results showed a high similarity between the outcomes of the two methods. An essential difference was noticed for the outcomes of the equation factors after application to the Leuenberger equation.

Conclusion: The approach with the NIRS is suggested as a promising tool for a reliable inline quality monitoring in the tablet manufacturing process.     

Single and Dual Drug Release Patterns from Shellac Wax-Lutrol Matrix Tablets Fabricated with Fusion and Molding Techniques

The objective of this investigation was to prepare the shellac wax matrix tablets by fusion and molding technique incorporated with Lutrol in different ratios to modify the hydrophobicity of matrix tablet. The matrix tablets with single drug were loaded either with propranolol hydrochloride or hydrochlorothiazide as hydrophilic and hydrophobic model drugs, and a dual drug formula was also prepared. The single and dual drug release patterns were studied in a dissolution apparatus using distilled water as medium. Propranolol hydrochloride released from matrix was easier than hydrochlorothiazide. Drug release from shellac wax matrix could be enhanced by incorporation of Lutrol. However retardation of drug release from some matrix tablets was evident for the systems that could form dispersion in the dissolution medium. The gel network from high content of Lutrol was hexagonal which was a dense and more compact structure than the other structures found when low amounts of Lutrol were present in the formula. Therefore, the formulae with high content of Lutrol could prolong drug release more efficiently than those containing low content of Lutrol. Hence shellac wax matrix could modulate the drug release with the addition of Lutrol. Sustainable dual drug release was also obtained from these developed matrix tablets. Thus shellac wax-Lutrol component could be used as a potential matrix tablet prepared with fusion and molding technique with excellent controlled drug release.