Application of Similarity Factor in Development of Controlled-Release Diltiazem Tablet

Controlled-release grade hydroxypropylmethylcellulose (HPMC) or xanthan gum (XG) and microcrystalline cellulose (MCC) were employed to prepare controlled-release diltiazem hydrochloride tablets. The similarity factor f₂ was used for dissolution profile comparison using Herbesser 90 SR as a reference product. Drug release could be sustained in a predictable manner by modifying the content of HPMC or XG. Moreover, the drug release profiles of tablets prepared using these matrix materials were not affected by pH and agitation rate. The f₂ values showed that only one batch of tablets (of diltiazem HCl, HPMC or XG, and MCC in proportions of 3.0:3.0:4.0) was considered similar to that of the reference product, with values above 50. The unbiased similarity factor f*₂ values were not much different from the f₂ values, ascribing to a small dissolution variance of the test and reference products. The amount of HPMC or XG incorporated to produce tablets with the desired dissolution profile could be determined from the curves of f₂ versus polymer content. Hence, the f₂ values can be applied as screening and optimization tools during development of controlled-release preparations.     

A Novel Imaging Technique to Investigate the Influence of Atomization Air Pressure on Film–Tablet Interfacial Thickness

A novel X-ray photoelectron spectroscopic (XPS) technique combined with principal component analysis of spectra-to-image datasets was employed to study the effects of atomization air pressure used during the coating process on film–tablet interfacial thickness. Placebo tablet cores were prepared and coated with Eudragit^® RL 30 D. Atomization air pressure was varied from 10 to 20 psi, whereas all other processing parameters were held constant. Higher air pressures generally produced thinner interfaces, although the interfacial region was not uniform across the tablet surface and was dependent on the sampling location. These results demonstrate the suitability of this XPS technique to study the coating–tablet interface. Moreover, the variability in the interfacial thickness illustrates the need to further study such systems.     

桑椹片中多酚及花青素含量的测定

采用Folin-Ciocaiteu法测定桑椹片中总多酚含量,通过HPLC法分析其中花青素的主要花青素单体及含量,及运用pH示差法测定其总花青素含量。该桑椹片的总多酚含量63.76 mg GAE/g,总花青素含量为6.63 mg/g;从HPLC花青素谱图中主要检测到矢车菊素-3-葡萄糖苷、矢车菊素-3-芸香苷这两种单体,其含量分别为2.91 mg/g和2.55 mg/g,含量之比1.14:1。该方法在2~500 μg/mL有很好的线性关系1.0000~0.9999,平均回收率102.5~97.8%,RSD为0.93~1.01%。研究结果表明,该方法更为灵敏、准确、重现性好,通过HPLC方法建立,综合了多酚和花青素单体的含量及其比例的测定能够有效地对桑椹片的质量控制。     

啤酒花口含片的研制

采用正交实验法,优选出啤酒花口含片的最佳工艺参数和生产工艺条件。研究结果表明：功效成分六氢β-酸用量为0.03%、糖粉为55%、白糊精为25%、薄荷脑包埋物为3%,经混合、湿法制粒、干燥和压片等工艺可制得啤酒花口含片。     

盐酸羟考酮控释片治疗中、重度癌痛的临床观察

目的观察盐酸羟考酮控释片(奥施康定)治疗晚期中、重度癌痛的临床效果、不良反应及患者生活质量的改善情况。方法102例中、重度癌痛患者给予奥施康定镇痛治疗,初始剂量5～10mg/q12h,正在用吗啡类镇痛药者,按照吗啡1/2剂量换算,使用过多瑞吉贴剂按25ug/h换算奥施康定15mg/q12h计算。根据疼痛情况调整剂量,直至患者疼痛评分≤2分,每位患者至少治疗15d以上,同时进行疼痛强度、生活质量评分及不良反应观察。结果奥施康定的最终滴定剂量为20～240mg/d,中位剂量50mg/d。总疼痛缓解率为91%,其中完全缓解42例(42%),明显缓解36例(36%),中度缓解13例(13%)。患者生活质量明显提高,不良反应主要为便秘,治疗后可缓解。结论盐酸羟考酮控释片治疗中、重度癌性疼痛疗效显著,不良反应可耐受,能显著改善癌症患者的生活质量。     

聚丙烯压塑试样制备的最佳操作条件

将聚丙烯粒料或粉料放入准备好的模具中,把模具放入压片机中进行加热和加压,制得热塑性塑料试样。为了更好的指导生产操作,我们一直在探索更省时、更方便、效果更好的压塑试样的条件,经过大量的试验条件的摸索和改进,得了理想的试验条件,本文主要针对聚丙烯压塑试样制备过程中的试验条件进行分析,得出一些改进经验。     

HPLC法同时测定精制冠心片中芍药苷和丹参酮ⅡA含量

建立同时测量精制冠心片中主药有效成分芍药苷和丹参酮ⅡA含量的方法。采用ODS—C18色谱柱(4.6 mm×250 mm,5μm),流动相采用乙睛-0.2%磷酸溶液进行梯度洗脱,流速1.0 mL/min,检测波长270 nm(检测丹参酮ⅡA),10 min,230 nm(检测芍药苷),柱温室温。结果表明,芍药苷在12.52～125.2μg/mL的范围内峰面积积分值与浓度呈良好的线性关系(r=0.999 8),平均回收率为100.1%,RSD=2.4%(n=6);丹参酮ⅡA在2.67～26.7μg/mL的范围内峰面积积分值与浓度呈良好的线性关系(r=0.999 9),平均回收率为100.2%,RSD=1.8%(n=6)。该法准确、简便,重现性好,可用于精制冠心片的质量控制。     

基于TRIZ冲突解决理论的平板电脑包装创新设计

通过平板电脑包装的市场调研,建立平板电脑系统的功能模型。发现问题:运用TRIZ的冲突解决理论确定冲突种类,将冲突一般化确定需改善的工程参数与恶化的工程参数,根据冲突矩阵提供的发明原理局部质量、多用性的思想,设计凹槽、抽屉、衬垫、弯折、支撑等结构,使得结构具有良好的缓冲与强度,并充分发挥了抽屉与展示的功能,使系统具有保护产品与展示促进销售双重功能。     

烟浪丁片剂储存稳定性实验研究

对烟浪丁片剂储存过程中的药物含量进行了追踪检测。结果表明，该制剂在存储过程发生了不同程度的分解，对存放 ２４ 个月左右的药片，测定的标示含量仅是设计含量的一半。     

改善扑热息痛片崩解时限和溶出度的研究

以羧甲基淀粉钠（CMS－Na)、低取代羟丙基纤维素（L－HPC）作为辅料，对原扑热息痛片生产工艺进行改进，通过正义试验法筛选出合适处方。结果表明：本方法的采用，不仅大大提高了扑热息痛片的硬度，而且改善了扑热息痛片的崩解时限和溶出度，产品质量显著提高。