法莫替丁胃内漂浮型双层缓释片的研究

目的研制法莫替丁胃内漂浮型双层缓释片并考察其体外释药行为。方法分别以湿法制粒的方法制备速释层和缓释层,压制胃内漂浮型双层片,紫外分光光度法测定法莫替丁的释放度,并记录起漂时间和持续漂浮时间。结果法莫替丁胃内漂浮型双层缓释片的释药曲线用Higuchi方程拟合,可维持24h持续释放,起漂时间〈5min,持续漂浮时间〉8h。结论研制的法莫替丁胃内漂浮型双层缓释片制备工艺简单,质量稳定,释药速度平稳,达到设计要求。     

薄层扫描法测定元胡止痛片中延胡索乙素的含量

目的：制定元胡止痛片中延胡索乙素含量测定方法。方法：双波长薄层扫描法,以苯－石油醚（９０～１２０℃）－甲醇－三氯甲烷（３：３：０．５：１０）为展开剂,检测波长３４０ｎｍ,参比波长３６５ｎｍ。结果：回收率平均为９７．６％（ＲＳＤ＝１．７９％,ｎ＝５）。标准曲线ｒ＝０．９９９８,线性范围０．２～１．２ｕｇｊ。结论：本方法简便,准确,可作为元胡止痛片的质量标准。     

妇乐片治疗慢性盆腔炎疗效观察

目的：观察妇乐片治疗慢性盆腔炎的临床疗效。方法将180例慢性盆腔炎患者分为治疗组120例和对照组60例,治疗后比较2组疗效。结果治疗组总有效率96．67％高于对照组的80．00％,差异有统计学意义（ P＜0．05）。结论妇乐片用于治疗慢性盆腔炎可彻底清除病灶,不良反应小,不易产生抗药性,服用方便。     

炔雌醇环丙孕酮片治疗多囊卵巢综合征临床分析

目的：探讨炔雌醇环丙孕酮片治疗多囊卵巢综合征（PCOS）的临床效果。方法：选择本院收治的66例多囊卵巢综合征患者,全部PCOS患者都从撤药流血或者月经流血第5天起,每天晚上服用1片炔雌醇环丙孕酮片,连续服用21d。然后在撤药撤血第5天开始重复使用炔雌醇环丙孕酮片,共使用6个周期。观察治疗前后体征参数、性激素水平和血糖代谢水平。结果：多囊卵巢综合征患者在治疗后,多毛体征和痤疮严重程度大为减轻,而且卵巢的体积显著减小,黄体生成素、黄体生成素/空腹胰岛素、总睾酮均显著下降（P〈0.05）,血糖代谢不受影响（P〉0.05）。治疗前正常排卵者3例,治疗后正常排卵者45例。结论：炔雌醇环丙孕酮片对多囊卵巢综合征患者有显著的抗激素作用,对血糖代谢无不良影响,促进排卵,能显著降低雄激素和相关体征。     

Iron oxide induced enhancement of mucoadhesive potential of Eudragit RLPO: formulation,evaluation and optimization of mucoadhesive drug delivery system

Objectives: The objective of the study was to investigate the effect of iron oxide in the development of mucoadhesive tablets of cinnarizine using Eudragit RLPO polymer. A simplex lattice design was employed for optimizing the drug delivery system.

Methods: Different concentrations of Eudragit RLPO (X₁), iron oxide (X₂) and PVP K 30 (X₃) were taken as independent variables and mucoadhesive strength, t_50%, t_90%, MDT and tablet tensile strength were the selected response variables. Contour and 3D plots were drawn to portray the relationship between independent and response variables. Ex vivo studies were performed for the determination of mucoadhesive strength of formulated tablets employing texture analyzer. ATR-FTR, DSC and zeta potential determination were conducted for drug-excipient and ionic interaction studies.

Results: Friability, hardness and tensile strength of mucoadhesive tablet formulation were found to be 0.42 ± 0.21%, 3.93 ± 1.57 kg/cm² and 0.65 ± 0.26 mN/m², respectively. Mucoadhesive strength was found to be ranging between 5.75 ± 4.41 and 42.85 ± 3.94 g. Value of release exponent (n) was found to be 0.65 ± 0.22, indicating anomalous drug release behavior from the formulations. Numerical optimization using the desirability approach was employed for developing optimized formulation by setting constraints of the dependent and independent variables. The mucoadhesive tablet formulation composition consisting of 8.58% w/w Eudragit RLPO, 7.02% w/w iron oxide and 7.26% w/w PVP K 30 fulfilled maximum requirements of an optimum formulation with better regulation of the selected constraints.

Conclusions: Eudragit RLPO and iron oxide combination showed high level potential for fabricating gastroretentive as well as mucoadhesive drug delivery systems.     

米非司酮联合去氧孕烯炔雌醇片治疗更年期功能失调性子宫出血的临床疗效分析

目的 探讨米非司酮联合去氧孕烯炔雌醇片治疗更年期功能失调性子宫出血的临床疗效.方法 回顾性分析2014年12月—2015年11月收治的90例更年期功能失调性子宫出血的患者的临床资料,根据治疗方法分为米非司酮组(米非司酮治疗)和联合用药组(米非司酮联合去氧孕烯炔雌醇片治疗),比较两组治疗前后的性激素包括雌激素(E2)、促卵泡生成素(FSH)以及黄体生成素(LH)浓度,止血时间以及临床疗效.结果 联合用药组治疗后E2、FSH以及LH浓度均明显低于治疗前和米非司酮组(P<0.05).联合用药组控制止血时间和完全止血时间较米非司酮组短(P<0.01);联合用药组治疗有效率明显高于米非司酮组,不良反应发生率低于米非司酮组(P<0.05).结论 米非司酮联合去氧孕烯炔雌醇片治疗更年期功能失调性子宫出血是一种安全有效的治疗方法.     

毛细管电泳法同时测定三黄片中7种有效成分的含量

目的:建立同时测定三黄片中7种有效成分——汉黄芩苷、汉黄芩素、大黄素、芦荟大黄素、大黄酸、大黄酚、大黄素甲醚含量的方法。方法:采用毛细管电泳法。内标为对乙酰氨基酚;毛细管柱为未涂层弹性融硅石英柱,有效长度为47 cm;运行缓冲液为25 mmol.L-1硼砂溶液+25 mmol.L-1十二烷基硫酸钠+4 mmol.L-1磺丁基β-环糊精+8%甲醇(pH 9.42);分离电压为14 kV;重力进样时间为5 s(高度为15 cm);检测波长为254 nm;温度25℃;湿度<70%。结果:7种有效成分检测浓度分别在2.02～20.16、1.00～10.00、1.60～16.00、1.20～12.00、2.00～20.00、7.20～72.00、1.00～10.00μg.mL-1范围内与各自峰面积积分值线性关系良好;回收率分别为100.6%、98.3%、99.9%、101.2%、99.8%、102.0%、101.8%,RSD均<3.0%。结论:本方法专属性强、结果准确可靠、重复性好,可用于三黄片的质量控制。     

健脾消胀片对大鼠胃酸含量、胃蛋白酶活力及胃肠电活动影响

目的探讨健脾消胀片对大鼠胃酸含量、胃蛋白酶活力及胃肠电活动的影响。方法结扎大鼠幽门与十二指肠结合部造模,测大鼠胃酸含量和胃蛋白酶活力;用EGEG-8D胃肠电图仪记录5 min大鼠胃电图,测量频率和幅值,以观察健脾消胀片对大鼠胃窦电活动、小肠电活动的影响。结果大、中剂量健脾消胀片组可使大鼠胃酸含量显著升高,大剂量健脾消胀片组可使大鼠胃蛋白酶活性显著升高,中剂量健脾消胀片组可使大鼠胃蛋白酶活性明显升高;大、中剂量健脾消胀片组可使大鼠胃窦电活动频率显著升高,小剂量健脾消胀片组可使大鼠胃窦电活动频率明显升高,大、中、小剂量健脾消胀片组可使大鼠胃窦电活动幅值显著升高;大、中、小剂量健脾消胀片组可使大鼠小肠电活动频率和幅值均显著升高。结论健脾消胀片具有消食和胃的临床意义。     

Prediction of oral disintegration time of fast disintegrating tablets using texture analyzer and computational optimization

One of the promising approaches to predict in vivo disintegration time of orally disintegrating tablets (ODT) is the use of texture analyzer instrument. Once the method is able to provide good in vitro in vivo correlation (IVIVC) in the case of different tablets, it might be able to predict the oral disintegration time of similar products. However, there are many tablet parameters that influence the in vivo and the in vitro disintegration time of ODT products. Therefore, the measured in vitro and in vivo disintegration times can occasionally differ, even if they coincide in most cases of the investigated products and the in vivo disintegration times may also change if the aimed patient group is suffering from a special illness. If the method is no longer able to provide good IVIVC, then the modification of a single instrumental parameter may not be successful and the in vitro method must be re-set in a complex manner in order to provide satisfactory results. In the present experiment, an optimization process was developed based on texture analysis measurements using five different tablets in order to predict their in vivo disintegration times, and the optimized texture analysis method was evaluated using independent tablets.     

复方磺胺甲噁唑片微生物限度检查方法验证

目的建立复方磺胺甲噁唑片的微生物限度检查方法。方法采用5种阳性对照菌对复方磺胺甲噁唑片进行微生物限度检查方法验证。通过回收率试验测定药物的抑菌性。结果采用培养基稀释法检验复方磺胺甲噁唑片,人工加入5种菌液,稀释剂对照组的回收率均高于70％;试验组回收率均高于70％。结论对复方磺胺甲噁唑片进行微生物限度检查。细菌数测定采用培养基稀释法检验．霉菌及酵母菌数测定采用常规法检验,控制菌检查采用薄膜过滤法。