RP-HPLC法测定金银花及金芪降糖片中的绿原酸

目的 建立同时测定金银花及金芪降糖片中绿原酸的反相高效液相色谱法。方法 色谱柱为Diamondsil C18（250 mm×4.6 mm，5 μm），以乙腈0.4%磷酸溶液（13∶87）为流动相，检测波长为327 nm，体积流量为1.0 mL/min。结果 在上述条件下测定金银花中绿原酸为2.49%，金芪降糖片中绿原酸为8.776 mg/片。结论 本方法操作简单、结果准确、回收率高、重现性好，可用于金银花及金芪降糖片的质量控制。     

新癀片外敷预防持续静脉推注5-Fu致静脉炎的临床研究

目的　寻找预防便携式弹性输液泵持续静脉推注 5 -Fu致静脉炎的有效方法。方法　随机将 15 0例用 5 -Fu化疗的病人分为 3组 ,各组 5 0例。对照组 :采用常规法 ,即输液前先静脉注射生理盐水 10ml+地塞米松 5mg ,以后冲管 1次 d(生理盐水 10ml静脉注射 ) ,每一疗程药物输注结束再续生理盐水 10 0ml冲管 ;实验组Ⅰ、Ⅱ :常规法加局部皮肤抹药 ,即将新癀片研成粉末加少许 75 %酒精调成糊状 ,沿静脉走向涂抹于输注部位上段皮肤 ,Ⅰ组涂抹长度为 5cm以上 ,Ⅱ组为 3～ 4cm ,每天涂药 :Ⅰ组 4次 ,Ⅱ组 3次 ,每疗程结束后继续皮肤抹药 1d。结果　Ⅰ组静脉炎发生例数为 0 ,Ⅱ组静脉炎发生例数为 2 (4 % ) ,对照组 5 0例均发生静脉炎 (10 0 % ) ;Ⅰ、Ⅱ组间比较无统计学意义 (P >0 .0 5 ) ,而Ⅰ、Ⅱ组与对照组比较有统计学意义 (P <0 .0 0 1)。结论　采用新癀片外敷预防持续静脉推注 5 -Fu所致的静脉炎效果可靠 ,且安全。     

自拟消鼽汤协定方对过敏性鼻炎患者中医证候积分及转化生长因子-α、白细胞介素-4水平变化的影响

目的:研究自拟消鼽汤协定方对过敏性鼻炎患者中医证候积分及转化生长因子-α(TGF-α)、白细胞介素-4(IL-4)水平变化的影响。方法:选取我院收治的过敏性鼻炎患者60例作为研究对象,随机分组,各30例。对照组给予西医常规治疗,观察组在对照组基础上给予自拟消鼽汤协定方治疗。比较两组治疗效果、治疗前后中医证候积分、血清炎性因子(TGF-α、IL-4)水平。结果:与对照组总有效率73.33%(22/30)相比,观察组93.33%(28/30)较高(P<0.05);治疗4周后,两组喷嚏、鼻痒、流涕、鼻塞积分较治疗前显著降低,且与对照组相比,观察组较低(P<0.05);治疗4周后,两组血清TGF-α、IL-4水平较治疗前显著降低,且与对照组相比,观察组较低(P<0.05)。结论:自拟消鼽汤协定方治疗过敏性鼻炎患者疗效显著,可明显改善临床症状,减轻炎症反应。     

不同剂量~(60)Co-γ射线辐照对三黄片中大黄粉含量及消毒效果的影响

为了解不同辐射剂量60Co-γ射线辐照灭菌对三黄片主要成分大黄素、大黄酚含量及消毒效果的影响,采用高效液相色谱法及细菌检验方法,对辐照处理的三黄片中大黄素、大黄酚和辐照消毒效果进行了检测。结果,三黄片经不同辐照剂量60Co-γ射线辐照前后,其主要成分大黄素、大黄酚的含量无明显的变化;辐照剂量为2 kGy的照度下即可以达到消毒要求。结论,三黄片用60Co-γ射线辐照消毒方法对其有效成分基本无影响,消毒效果可靠。     

Preparations based on minerals extracts of Calicotome villosa roots and bovine butyrate matter: Evaluation in vitro of their antibacterial and antifungal activities

Objective

The use of preparations based on minerals extracts of Calicotome villosa and butter is born from the misuse of drugs without specific microbiological analyzes. Seventeen different preparations were performed. The antibacterial and antifungal activities were determined on five bacteria and two fungi strains respectively.

流化床制粒制备甘芝口含片

目的：制备甘芝口含片。方法：采用流化床制粒,以颗粒流动性、含片崩解时限及外观性状为考察指标,通过正交试验优选最佳制粒工艺参数。结果：最佳工艺参数为A1B2C3D3,即进风温度为45～50℃、物料温度40～45℃,雾化压力0.8～1.0bar,料液流速5～7ml/min。结论：该制备工艺简单,方法可行,可应用于大生产。     

散结镇痛片对子宫内膜异位症模型大鼠妊娠功能和激素水平的影响

目的 观察散结镇痛片对子宫内膜异位症模型大鼠妊娠功能和雌激素水平的影响.方法 采用自体种植法制备大鼠子宫内膜异位症模型.手术后将大鼠分为假手术组,模型组,达那唑胶囊(0.070 g/kg)阳性对照组,散结镇痛片低、中、高剂量(0.216、0.432、0.864 g/kg)组及散结镇痛胶囊(0.864 g生药/kg)组,...     

Combining experimental design and orthogonal projections to latent structures to study the influence of microcrystalline cellulose properties on roll compaction

Roll compaction is gaining importance in pharmaceutical industry for the dry granulation of heat or moisture sensitive powder blends with poor flowing properties prior to tabletting. We studied the influence of microcrystalline cellulose (MCC) properties on the roll compaction process and the consecutive steps in tablet manufacturing. Four dissimilar MCC grades, selected by subjecting their physical characteristics to principal components analysis, and three speed ratios, i.e. the ratio of the feed screw speed and the roll speed of the roll compactor, were included in a full factorial design. Orthogonal projection to latent structures was then used to model the properties of the resulting roll compacted products (ribbons, granules and tablets) as a function of the physical MCC properties and the speed ratio. This modified version of partial least squares regression separates variation in the design correlated to the considered response from the variation orthogonal to that response. The contributions of the MCC properties and the speed ratio to the predictive and orthogonal components of the models were used to evaluate the effect of the design variation. The models indicated that several MCC properties, e.g. bulk density and compressibility, affected all granule and tablet properties, but only one studied ribbon property: porosity. After roll compaction, Ceolus KG 1000 resulted in tablets with obvious higher tensile strength and lower disintegration time compared to the other MCC grades. This study confirmed that the particle size increase caused by roll compaction is highly responsible for the tensile strength decrease of the tablets.     

通关灵片药效学研究

目的考察通关灵片的药效学。方法选择对正常小鼠肠推进运动试验、小鼠排便时间和数量试验,以及模拟燥结失水便秘3个药效试验。结果与结论对正常小鼠肠推进运动试验研究表明,通关灵片各组均有较好的推进作用,中剂量组与对照组比较有非常显著差别(P<0.01),高剂量组与对照组比较有显著差别(P<0.05),阳性对照组与溶媒对照组比较有作用趋势,正常小鼠小肠容积变化不明显,阳性对照组小肠容积变化明显。正常小鼠排便时间和数量试验结果表明,给药后小鼠出现黑便时间较短,高剂量组与溶媒对照组比较有显著差别(P<0.05);高剂量组与溶媒对照组比较,排便数量有非常显著差别(P<0.01),其余各组与溶媒对照组比较有作用趋势。燥结失水便秘试验中,通关灵片各组与模型组比较均有作用趋势,差别无显著意义。     

Food-dependent disintegration of immediate release fosamprenavir tablets: In vitro evaluation using magnetic resonance imaging and a dynamic gastrointestinal system

In the present study, we demonstrated the value of two advanced tools, the TNO gastric and small Intestinal Model (TIM-1) and magnetic resonance imaging (MRI), for the in vitro evaluation of food-dependent disintegration of immediate release fosamprenavir tablets. Upon introduction of a tablet with the nutritional drink Scandishake Mix® in the stomach compartment of TIM-1, simulating the fed state, disintegration and fosamprenavir dissolution were significantly postponed compared to the fasted state (lag time 80 ± 23 min). This resulted in a lag in the appearance of bioaccessible fosamprenavir (<5% during the first 2 h), even though the nutritional state did not significantly alter the cumulative bioaccessibility after 5 h. These results were in agreement with the previously observed postprandial delay in gastric fosamprenavir tablet disintegration and subsequent amprenavir absorption in healthy volunteers. Therefore, TIM-1 can be used in tablet development to identify food-induced disintegration issues causing unexpected clinical behavior. From a mechanistic perspective, we applied MRI to illustrate impaired water ingress in fosamprenavir tablets immersed in the nutritional drink compared to simulated gastric fluid. This effect may be attributed to both competition between nutritional components and the tablet for the available water (indicated by reduced rotational and translational diffusion) as well as the possible formation of a food-dependent precipitation layer on the HPMC-coated tablet.