HPLC同时测定喘舒片中5种蒽醌类成分的含量

目的:建立HPLC法测定喘舒片(升华硫、大黄粉、黄芩提取物等)中5种蒽醌类成分的含量.方法:色谱柱:Lanbo(R) Kromasil C18柱,流动相:甲醇-0.3%磷酸(80∶20),柱温:30℃,流速:1.0 mL/min,检测波长:254 nm.结果:芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚平均回收率分别为97.47%,98.18%,97.75%,98.00%,98.06%,芦荟大黄素在进样量0.093 6～O.468 μg、大黄酸在进样量0.098～0.49μg、大黄素在进样量0.106～0.53μg、大黄酚在进样量0.232～1.16 μg、大黄素甲醚在进样量0.147 6～0.738μg范围内与峰面积呈良好线性关系.结论:该方法简便、灵敏、结果准确可靠,适用于该制剂中蒽醌类成分的质量控制.     

Wang痹片治疗类风湿性关节炎的研究

目的：观察Ｗａｎｇ痹片治疗类风湿性关节炎（ＲＡ）的临床疗效和作用机理。方法：观察组１００例采用Ｗａｎｇ痹片治疗,对照组５０例采用风湿马钱片治疗。另做药理实验。结果：观察组在总有效率、治愈率、ＥＳＲ复常率、ＲＦ转阴率等方面与对照组比较,均Ｐ〈０．０５（或Ｐ〈０．０１）。观察组总有效率为９４．００％。药理显示：Ｗａｎｇ痹片在消炎镇痛方面作用显著,能提高细胞免疫功能,抑制病情发展。结论：Ｗａｎｇ痹片治疗     

中联鼻炎片联合氯雷他定治疗变应性鼻炎疗效分析

目的:观察中联鼻炎片联合氯雷他定87635106治疗变应性鼻炎的疗效和安全性。方法:对照组60例用氯雷他定口服,治疗组60例在用氯雷他定同时口服中联鼻炎片,两组均治疗3周。观察的症状包括喷嚏、流涕、鼻塞和鼻痒,并进行4分法评分,计算出治疗后积分改善率。结果:治疗组显效率46.7%,有效率41.6%,无效率11.1%,总有效率88.3%;对照组显效率16.7%,有效率56.7%,无效率33.3%,总有效率73.3%。两组总有效率比较差异有显著性意义(P<0.01)。治疗组疗效明显优于对照组。两组均未发生不良反应。结论:氯雷他定联合中联鼻炎片能更有效地治疗变应性鼻炎,且无毒副作用。     

A new tablet brittleness index

Brittleness is one of the important material properties that influences the success or failure of powder compaction. We have discovered that the reciprocal of diametrical elastic strain at fracture is the most suitable tablet brittleness indices (TBIs) for quantifying brittleness of pharmaceutical tablets. The new strain based TBI is supported by both theoretical considerations and a systematic statistical analysis of friability data. It is sufficiently sensitive to changes in both tablet compositions and compaction parameters. For all tested materials, it correctly shows that tablet brittleness increases with increasing tablet porosity for the same powder. In addition, TBI increases with increasing content of a brittle excipient, lactose monohydrate, in the mixtures with a plastic excipient, microcrystalline cellulose. A probability map for achieving less than 1% tablet friability at various combinations of tablet tensile strength and TBI was constructed. Data from marketed tablets validate this probability map and a TBI value of 150 is recommended as the upper limit for pharmaceutical tablets. This TBI can be calculated from the data routinely obtained during tablet diametrical breaking test, which is commonly performed for assessing tablet mechanical strength. Therefore, it is ready for adoption for quantifying tablet brittleness to guide tablet formulation development since it does not require additional experimental work.     

Formulation and optimization of potassium iodide tablets

The use of potassium iodide (KI) as a protective agent against accidental radioactive exposure is well established. In this study, we aimed to prepare a KI tablet formulation using a direct compression method. We utilized Design of Experiment (DoE)/mixture design to define the best formulation with predetermined physical qualities as to its dissolution, hardness, assay, disintegration, and angle of repose. Based on the results from the DoE, the formulation had the following components (%w/w): Avicel 48.70%, silicon dioxide 0.27%, stearic acid (1.00%), magnesium stearate 2.45%, and dicalcium phosphate 18.69%, in addition to potassium iodide 28.89% (130 mg/tablet). This formulation was scaled-up using two tablet presses, a single-punch press and a rotary mini tablet press. The final scaled-up formulation was subjected to a variety of quality control tests, including photo-stability testing. The results indicate that potassium iodide tablets prepared by a rotary mini tablet press had good pharmaceutical characteristics and a shelf-life of 25 days when stored at room temperature protected from light.     

高效液相色谱法测定通脉降糖颗粒中盐酸小檗碱的含量

目的 :测定通脉降糖颗粒中盐酸小檗碱的含量。方法 :高效液相色谱法。SpherigelC1 8柱 ,乙腈 水 (55∶35)为流动相 ,每 1 0 0 0ml流动相中含磷酸二氢钾 3 .4g,十二烷基硫酸钠 1 .7g ,流速 1ml·min- 1 ,检测波长 345nm。结果 :通脉降糖颗粒中盐酸小檗碱与多种杂质能有效分离。盐酸小檗碱进样量在 0 .0 2 65～ 0 .2 1 2 0 μg范围内线性关系良好 ,γ =0 .9998。平均回收率为 1 0 1 .6 % (n =5 ,RSD =1 .8% )。结论 :本方法简便、快速、准确     

Figures of Merit Comparison of Reflectance and Transmittance Near-Infrared Methods for the Prediction of Constituent Concentrations in Pharmaceutical Compacts

The purpose of this work was to demonstrate how multivariate figures of merit, in conjunction with accuracy and precision statistics, can be used to evaluate the performance of near-infrared reflectance and transmittance spectroscopy for the nondestructive chemical quantification of intact pharmaceutical compacts. A total of 174 four-component compacts were produced at five compaction pressures following a fully balanced quaternary design. Near-infrared spectra were measured in both reflectance and transmittance modes. Partial least-squares regression was used to model spectroscopic response, and net analyte signal theory was used to generate the figures of merit. It was discovered that sample positioning variation more negatively impacted the performance (analytical sensitivity, S/N ratio, limit of detection) of the transmittance method. Process analytical technology implementation teams should consider these aspects during technology selection, method development, and validation.     

Real-time Acoustic Elastic Property Monitoring of Compacts During Compaction

A nondestructive, real-time acoustic technique for determining elastic properties of compacts during compaction is presented. An acoustic time-of-flight study was conducted, and the extraction of the linear elastic properties of calcium carbonate compacts was demonstrated. To verify the results of the acoustic experiments, a uniaxial compaction investigation was also carried out using a computer-controlled press with an instrumented die. Good agreement between linear elastic properties determined using both acoustic experiments and compaction force-displacement data was observed. This technique has the potential to be used as a real-time compaction monitoring tool.     

中药治疗输卵管结扎术后遗症100例

目的：为观察和验证黄芪通脉汤对闭塞性动脉硬化（ＡＳＯ）患者血脂的调节作用。方法：选择ＡＳＯ患者３２例，应用黄芪通脉汤煎剂内服法治疗２个月，观察治疗前后血脂水平的变化。结果：治疗后患者血清高密度脂蛋白胆固醇升高、低密度脂蛋白胆固醇降低、动脉硬化指数下降（Ｐ＜０．０１）；血清胆固醇与甘油三酯、极低密度脂蛋白胆固醇、载脂蛋白（ａｐｏＡ１、ａｐｏＢ１００）均有变化（Ｐ均＜０．０５），ａｐｏＡ／ａｐｏＢ比值升高。结论：黄芪通脉汤具有明显的调脂作用。     

葛根通脉饮对HCY家兔AS斑块和环磷酸腺苷反应元件结合转录因子同源蛋白表达的影响

目的:观察葛根通脉饮对同型半胱氨酸(homocysteine,HCY)所致家兔动脉粥样硬化(atherosclerosis,AS)血管损伤和内质网应激(ERS)相关分子C/EBP环磷酸腺苷反应元件结合转录因子同源蛋白(C/EBP-homologousprotein,CHOP)表达的影响,并探讨其分子机制。方法:将36只日本大耳白兔随机等分成6组。对照组饲喂基础饲料,模型组饲喂高脂饲料(基础饲料+1%胆固醇及0.02%蛋氨酸),可定组(1 mg·kg-1+高脂饲料)、葛根通脉饮低、中、高剂量组(5,7.5,10 g·kg-1+高脂饲料),通过高脂饮食9周复制兔动脉粥样硬化模型。取胸主动脉观察其病理改变,用组织原位杂交和Western-blotting检测胸主动脉CHOP分子表达水平。结果:形态学显示模型组血管内膜下形成典型的脂质斑块,可定组内膜下有少量的斑块形成,病变较模型组轻,葛根通脉饮低剂量组血管局部区域出现脂质斑块,葛根通脉饮中剂量组血管内膜结构紊乱,葛根通脉饮高剂量组血管内膜下有少量平滑肌细胞增生。组织原位杂交结果显示,各组中CHOP基因在血管内膜和中膜层细胞胞质中均有表达,对照组内皮细胞和平滑肌细胞胞质中可见少量棕黄色颗粒。模型组斑块结构中平滑肌细胞和泡沫细胞胞质中棕黄色颗粒高表达。与模型组比葛根通脉饮组平滑肌细胞阳性信号表达下降。Western-blotting杂交结果显示,CHOP蛋白在各组中均有表达,与对照组比较模型组CHOP蛋白表达增多,差异有统计学意义(P<0.01);与模型组比较在葛根通脉饮低、中、高剂量组中CHOP蛋白表达减少,差异均显著(P<0.01)。结论:葛根通脉饮抗AS作用机制可能与ERS相关分子CHOP的表达密切相关。可通过拮抗HCY所诱导AS的血管损伤,降低ERS相关分子CHOP在家兔胸主动脉中的表达。