扑尔敏霜剂的研制与质量控制及临床疗效观察

目的 :制备扑尔敏霜剂 ,建立其质量控制方法并观察其临床疗效。方法 :采用乳化法制备扑尔敏霜剂 ,以紫外分光光度法测定霜剂中扑尔敏的含量 ,初匀速法考察制剂稳定性。结果 :扑尔敏检测浓度在10～30μg/ml范围内呈良好线性关系 (r=0 9999) ,平均回收率为101 25 %,RSD=1 28 %;临床应用总有效率为97 66 %。结论 :该制剂性质稳定 ,质量可控 ;临床应用安全、有效。     

高效液相色谱法同时测定小儿氨酚黄那敏颗粒剂中二组分的含量

目的建立一种用反相高效液相色谱法,同时测定小儿氨酚黄那敏颗粒中对乙酰氨基酚和马来酸氯苯那敏含量的方法。方法采用RP-HPLC法,以Sh im-pack VP-ODS(150mm×4.6mm,5μm)为色谱柱,甲醇-水-冰醋酸(40∶60∶0.5)为流动相,检测波长(λ)为:261 nm,流速:1.0 mL/m in,柱温:40℃,面积外标法定量。结果对乙酰氨基酚、马来酸氯苯那敏线性范围分别在40~280μg.mL-1,0.32~2.24μg.mL-1;浓度范围内呈现出良好的线性关系,方法平均回收率分别为:98.85%,97.97%(n=3)。相关系数r=0.999 9,r=0.999 7,RSD为0.81%,1.76%(n=5)。结论该方法简便、快速,二组分分离度好,其他成分无干扰,测定结果准确可靠,可作为该制剂质量控制的有效方法。     

马来酸曲美布汀联合门诊森田疗法治疗肠易激综合征的临床研究

目的 :观察马来酸曲美布汀联合门诊森田疗法治疗肠易激综合征 (irritablebowelsyndrome ,IBS)的临床疗效。方法 :10 8例患者随机分为 2组。马来酸曲美布汀组 5 4例 :2 0 0mg马来酸曲美布汀 ,po ,tid ,配合门诊森田心理疗法 ,治疗前、后以焦虑自评量表 (SAS)和抑郁自评量表 (SDS)评定疗效 ;对照组5 4例 :仅用 2 0 0mg马来酸曲美布汀 ,po ,tid ,2组疗程均为 4周。结果 :马来酸曲美布汀组和对照组总有效率分别为 87.0 4 %与 72 .2 2 % ,马来酸曲美布汀组明显优于对照组 (P <0 .0 5 )。马来酸曲美布汀组治疗后SAS、SDS评分与对照组比较均有明显下降(P <0 .0 1)。马来酸曲美布汀组 6月复发率与对照组比较明显降低 (P <0 .0 1)。结论 :马来酸曲美布汀联合门诊森田疗法是治疗肠易激综合征更有效的治疗方法。     

高效液相色谱法测定小儿氨酚黄那敏颗粒中马来酸氯苯那敏含量

目的建立高效液相色谱法(HPLC)测定小儿氨酚黄那敏颗粒中马来酸氯苯那敏的含量及含量均匀度。方法采用C18柱(4.6 mm×250 mm，5 μm)，流动相：甲醇 0.5 mol·L^-1磷酸二氢钠 三乙胺(150∶850∶0.25)，用磷酸调节pH值至2.3，流速1 mL·min^-1，检测波长215 nm，外标法测定含量。结果马来酸氯苯那敏在0.05～0.50 μg的进样量范围内线性关系良好，r＝0999 8，平均回收率96.0%，RSD＝0.9%(n＝5)。结论该法简便，快速，重现性好。     

贯黄感冒颗粒(无糖型)质量标准研究

目的建立贯黄感冒颗粒(无糖型)的质量控制标准。方法采用薄层色谱法鉴别制剂中的路边青和马来酸氯苯那敏；采用高效液相色谱法对马来酸氯苯那敏进行含量测定。结果马来酸氯苯那敏线性范围在0．2～1．2ug，相关系数r=0．9999；回收率96．8％，变异系数为1．2％(n=5)。结论本法简便，快速，测定结果准确，可以用于贯黄感冒颗粒(无糖型)的质量控制。     

曲伏前列素滴眼液治疗原发性开角型青光眼的临床效果

目的分析曲伏前列素滴眼液治疗原发性开角型青光眼的临床效果。方法将42例原发性开角型青光眼患者随机分为对照组和研究组,每组21例。对照组实施马来酸噻吗洛尔滴眼液治疗,研究组实施曲伏前列素滴眼液治疗,比较两组的临床效果。结果治疗后,研究组的眼压、视力、散光度、基础泪液分泌量、泪膜破裂时间、血浆粘度、全血粘度低切、全血粘度高切均优于对照组(P<0.05)。结论曲伏前列素滴眼液治疗原发性开角型青光眼的临床效果确切,值得临床推广应用。     

Study on the Mechanism Responsible for the Incompatibility of Enalapril Maleate with Sodium Starch Glycolate

Enalapril maleate (EM) is known to suffer from incompatibilities in the solid state. This study investigates the destabilizing effect of sodium starch glycolate (SSG) on EM. This was done by varying the mixing ratio and moisture content of binary mixtures. Differential scanning calorimetry and microscopy show a loss of crystallinity of EM at the contact surface with SSG. It is shown that this is followed by decomposition of E to diketopiperazine (DKP). These phenomena are modulated by moisture. The environmental pH turned out to be crucial; when the zwitterion is formed at the appropriate pH, ring closure into DKP is promoted.     

A cost-effectiveness analysis of enalapril maleate in the management of congestive heart failure in Australia

Background: This study is motivated by the results of the SOLVD treatment trial (N Engl J Med 1991; 325: 293-302) which demonstrated the clinical efficacy of enalapril in the treatment of congestive heart failure but did not undertake an economic evaluation of enalapril therapy. Aims: To undertake a cost-effectiveness analysis of enalapril maleate versus placebo, in conjunction with conventional treatment, in the management of congestive heart failure in Australia. Methods: The published results from the SOLVD treatment trial are used to estimate the increase in survival, and the reduction in the number of hospitalisations, arising from the use of enalapril in the management of congestive heart failure. The costs of enalapril therapy are estimated using Australian data on the drug and non-drug costs of enalapril therapy and the costs of hospitalisation. Results: Enalapril therapy increases mean survival in heart failure patients by 1.68 to 1.80 months. The average additional drug and non-drug cost of enalapril therapy is estimated to be $1890 over a four year period, against which must be offset cost savings from a reduction in hospitalisations of $2060 to $2140. On balance, therefore, enalapril is cost saving, reducing health care costs for a congestive heart failure patient on average by SI70 to $250 over a four year period. This value is sensitive to estimates of cost offsets and of improved survival which can result in either a net cost saving with enalapril of approximately $1200 per patient or a net additional cost of up to $3000 per patient (over four years) or greater than $20,000 per life-year saved. Conclusions: The addition of enalapril to conventional management of congestive heart failure in Australia should improve survival and may provide a net reduction in treatment costs compared with conventional management alone.     

马来酸曲美布汀治疗肠易激综合征对比研究

目的探讨马来酸曲美布汀对肠易激综合征的治疗效果。方法将诊断为肠易激综合征（IBS）的97例患者随机分成试验组（47例）和对照组（50例），试验组给予马来酸曲美布汀，对照组使用复合维生素B作为安慰剂，两组疗程均为6周，治疗期间均停用其他药物，分别于治疗前及治疗的第2、4、6周及随访8、12周末进行症状评价及评分。结果试验组治疗后积分明显下降，治疗前后比较差异有非常显著性（P〈0．01）；对照组积分下降不明显，治疗前后比较差异无显著性（P〉0．05）；治疗4周后两组间比较，试验组积分下降较对照组明显，差异有非常显著性（P〈0．01）；治疗后两组疗效比较，试验组在2周后有效率达34％，8周和12周时分别达到83％和82％，疗效明显高于对照组，差异有非常显著性（P〈0．01）。结论马来酸曲美布汀对难治性功能性消化不良具有良好的治疗作用和安全性。     

HPLC测定复方氨肽素片中氨茶碱与马来酸氯苯那敏的含量及含量均匀度

目的 建立HPLC测定复方氨肽素片中氨茶碱与马来酸氯苯那敏的含量及含量均匀度。方法 色谱柱为YMC Hydrosphere C₁₈(4.6 mm×250 mm,5 μm),流动相为乙腈-0.5%磷酸溶液(用三乙胺调pH值至2.2)(10∶90),流速为1.0 mL·min^-1,柱温为30 ℃,检测波长为262 nm。结果 茶碱和马来酸氯苯那敏分别在0.06~0.58 mg·mL^-1和2.2~20.0 μg·mL^-1内线性关系良好,回收率分别为100.4%和101.2%,RSD分别为0.74%和1.40%(n=9)。结论 方法快速准确,重复性好,结果可靠,可同时测定氨茶碱及马来酸氯苯那敏,为产品质量标准提高提供基础。