桂枝茯苓丸联合妇乐片对子宫内膜异位症的临床疗效

目的:探讨桂枝茯苓丸联合妇乐片对子宫内膜异位症患者血清甲胎蛋白(AFP)、血清脂质结合唾液酸(LSA)及临床疗效的影响。方法:选取我院确诊并治疗的子宫内膜异位症患者68例,按随机数字表法进行分组,每组34例。对照组患者予以妇乐片口服治疗;研究组患者在对照组用药基础上予以桂枝茯苓丸联合治疗,所有患者连续服药6个月。观察两组患者治疗前后血清甲胎蛋白(AFP)、血清LSA、肿瘤坏死因子-α(TNF-α)及血管内皮生长因子(VEGF)水平的变化情况、临床疗效及不良反应发生率。结果:研究组治疗后临床有效率91.18%,高于对照组治疗后临床有效率70.59%,差异具有统计学意义(P0.05);与对照组比较,研究组治疗后血清AFP、LSA、TNF-α、VEGF水平降低,差异具有统计学意义(P0.05);对照组不良反应发生率为8.24%,研究组不良反应发生率为5.88%,两组间不良反应发生率无统计学意义(P0.05)。结论:采用桂枝茯苓丸联合妇乐片治疗子宫内膜异位症,能有效提高患者的临床疗效,推测其机制与降低血清AFP、LSA、TNF-α、VEGF水平有关。     

Trace analysis of N‐acetyl‐L‐cysteine using luminol–H2O2 chemiluminescence system catalyzed by silver nanoparticles

N‐Acetyl‐L‐cysteine (NAC) can inhibit the luminol–H₂O₂, reaction, which is catalyzed by silver nanoparticles. Based on this phenomenon a new method was developed for NAC determination. Under optimum conditions, a linear relationship between chemiluminescence intensity and NAC concentration was found in the range 0.034–0.98 µg/mL. The detection limit was 0.010 µg/mL (S/N =3), and the relative standard deviation (RSD) was <5% for 0.480 µg/mL NAC (n =5). This simple, sensitive and inexpensive method has been applied to measure the concentration of NAC in pharmaceutical tablets. Copyright © 2014 John Wiley & Sons, Ltd.     

胃复春片联合兰索拉唑肠溶片对慢性萎缩性胃炎患者血清胃肠激素、炎症因子及免疫功能的影响

摘要 目的：胃复春片联合兰索拉唑肠溶片对慢性萎缩性胃炎（CAG）患者血清胃肠激素、炎症因子及免疫功能的影响。方法：选取62例CAG患者,根据门诊挂号奇偶性分为对照组（n=31,兰索拉唑肠溶片治疗）和研究组（n=31,胃复春片联合兰索拉唑肠溶片治疗）。比较两组患者疗效、胃肠激素[胃泌素(GAS)、胃动素(MTL)]、炎症因子[超敏C反应蛋白（hs-CRP）、肿瘤坏死因子-α（TNF-α）、白介素-6（IL-6）]、免疫功能及不良反应。结果：研究组治疗2个月后的总有效率为87.10%（27/31）,高于对照组的64.52%（20/31）,差异有统计学意义（P<0.05）。治疗2个月后,研究组hs-CRP、TNF-α、IL-6、GAS、CD8P低于对照组,MTL、CD4P、CD4⁺/CD8⁺高于对照组（P<0.05）。两组不良反应发生率对比未见明显差异（P>0.05）。结论：胃复春片联合兰索拉唑肠溶片治疗CAG疗效确切,可有效改善机体胃肠激素、炎症因子水平及免疫功能,且安全可靠,具有一定应用价值。     

心血管领域复方创新药的范例：缬沙坦沙库比曲片 与依那普利叶酸片 ——给我国新药创制带来的启示

缬沙坦沙库比曲片与依那普利叶酸片均属于复方创新药,即其中单药在组成复方后的疗效或适应证发生新的变化。针对临床需求、 疗效以及循证依据,详细剖析这两种复方创新药的组方特点,重点探讨复方创新药与一般复方药的区别,为以临床价值为导向和基于患者 人群特点的重大新药创制提供借鉴。     

Development and evaluation of acid-buffering bioadhesive vaginal tablet for mixed vaginal infections

An acid-buffering bioadhesive vaginal tablet was developed for the treatment of genitourinary tract infections. From the bioadhesion experiment and release studies it was found that polycarbophil and sodium carboxymethylcellulose is a good combination for an acid-buffering bioadhesive vaginal tablet. Sodium monocitrate was used as a buffering agent to provide acidic pH (4.4), which is an attribute of a healthy vagina. The effervescent mixture (citric acid and sodium bicarbonate) along with a superdisintegrant (Ac-Di-sol) was used to enhance the swellability of the bioadhesive tablet. The drugs clotrimazole (antifungal) and metronidazole (antiprotozoal as well as an antibacterial) were used in the formulation along with Lactobacillus acidophilus spores to treat mixed vaginal infections. From the ex vivo retention study it was found that the bioadhesive polymers hold the tablet for more than 24 hours inside the vaginal tube. The hardness of the acid-buffering bioadhesive vaginal tablet was optimized, at 4 to 5 kg hardness the swelling was found to be good and the cumulative release profile of the developed tablet was matched with a marketed conventional tablet (Infa-V). The in vitro spreadability of the swelled tablet was comparable to the marketed gel. In the in vitro antimicrobial study it was found that the acid-buffering bioadhesive tablet produces better antimicrobial action than marketed intravaginal drug delivery systems (Infa-V, Candid-V and Canesten 1).     

Process analytical technology case study,part III: Calibration monitoring and transfer

This is the third of a series of articles detailing the development of near-infrared spectroscopy methods for solid dosage form analysis. Experiments were conducted at the Duquesne University Center for Pharmaceutical Technology to develop a system for continuous calibration monitoring and formulate an appropriate strategy for calibration transfer. Indcators of high-flux noise (noise factor level) and wave-length uncertainty were developed. These measurements, in combination with Hotelling’s T² and Q residual, are used to continuously monitor instrument performance and model relevance. Four calibration transfer techniques were compared. Three established techniques, finite impulse response filtering, generalized least squares weighting, and piecewise direct standardization were evaluated. A fourth technique, baseline subtraction, was the most effective for calibration transfer. Using as few as 15 transfer samples, predictive capability of the analytical method was maintained across multiple instruments and major instrument maintenance.     

Effect of humidity on the disintegrant property of α-cellulose,Part II: A technical note

Conclusion  The summary is that the high humidity impaired the disintegrant property of α-cellulose in all 3 tablets tested. Tablets of aspirin, which is the more hygroscopic drug, were also more sensitive to the humidity effect, while tablets of chloroquine phosphate, which is a water-soluble drug, were the least sensitive to the humidity effect. The results permit the conclusion that moisture uptake with subsequent gelling of the α-cellulose is the mechanism of impairment of its disintegrant property. The tablets would not normally be stored under an RH as high as 100%, nevertheless, the results of the accelerated stability study have underscored the need to protect tablets containing α-cellulose as disintegrant from moisture. Published: August 10, 2005     

Optimization of bilayer floating tablet containing metoprolol tartrate as a model drug for gastric retention

The purpose of the present study was to develop an optimized gastric floating drug delivery system (GFDDS) containing metoprolol tartrate (MT) as a model drug by the optimization technique. A 2³ factorial design was employed in formulating the GFDDS with total polymer content-to-drug ratio (X₁), polymer-to-polymer ratio (X₂), and different viscosity grades of hydroxypropyl methyl cellulose (HPMC) (X₃) as independent variables. Four dependent variables were considered: percentage of MT release at 8 hours, T_50%, diffusion coefficient, and floating time. The main effect and interaction terms were quantitatively evaluated using a mathematical model. The results indicate that X₁ and X₂ significantly affected the floating time and release properties, but the effect of different viscosity grades of HPMC (K4M and K10M) was nonsignificant. Regression analysis and numerical optimization were performed to identify the best formulation. Fickian release transport was confirmed as the release mechanism from the optimized formulation. The predicted values agreed well with the experimental values, and the results demonstrate the feasibility of the model in the development of GFDDS.     

Tablet formulation containing meloxicam and β-cyclodextrin: Mechanical characterization and bioavailability evaluation

The purpose of this research was to evaluate β-cyclodextrin (β-CD) as a vehicle, either singly or in blends with lactose (spray-dried or monohydrate), for preparing a meloxicam tablet. Aqueous solubility of meloxicam in presence of β-CD was investigated. The tablets were prepared by direct compression and wet granulation techniques. The powder blends and the granules were evaluated for angle of repose, bulk density, compressibility index, total porosity, and drug content. The tablets were subjected to thickness, diameter, weight variation test, drug content, hardness, friability, disintegration time, and in vitro dissolution studies. The effect of β-CD on the bioavailability of meloxicam was also investigated in human volunteers using a balanced 2-way crossover study. Phase-solubility studies indicated an A_L-type diagram with inclusion complex of 1∶1 molar ratio. The powder blends and granules of all formulations showed satisfactory flow properties, compressibility, and drug content. All tablet formations prepared by direct compression or wet granulation showed acceptable mechanical properties. The dissolution rate of meloxicam was significantly enhanced by inclusion of β-CD in the formulations up to 30%. The mean pharmacokinetic parameters (C_max, K_e, and area under the curve [AUC]_0−∞) were significantly increased in presence of β-CD. These results suggest that β-CD would facilitate the preparation of meloxicam tablets with acceptable mechanical properties using the direct compression technique as there is no important difference between tablets prepared by direct compression and those prepared by wet granulation. Also, β-CD is particularly useful for improving the oral bioavailablity of meloxicam.     

A microcomputer based method for the rapid and detailed measurement of seedling root systems

Summary A simple method for making detailed measurements of seedling root systems is described. Photocopies of root systems are traced over by an operator using a digitizing system attached to a microcomputer. The computer calculates and prints the lengths of axis, laterals and sublaterals for each root system. Accurate measurements can be achieved with a degree of speed and detail unobtainable by other methods.