Experimental study of reparative regeneration processes in the wound treated with bioactive dressings

Quantitative and structural functional analysis of granulation tissue cells during treatment with protein-polysaccharide dressing Collahit F was carried out. The preparation effectively cleansed the wound from detritus, prevented secondary infection due to stimulation of the functional activity of macrophages and due to the effect of its antiseptic component (furagin), and stimulated proliferative activity of fibroblasts and granulation tissue microvessels on day 5 of treatment, thus promoting repair processes in the wound.     

Regular tracheostomy tube changes to prevent formation of granulation tissue

OBJECTIVES/HYPOTHESIS: Tracheostomy is a commonly performed operative procedure that has been described since 2000 B.C. The early indications for tracheostomy were for upper airway obstruction, usually occurring in young people as a result of an infectious process. Recently, tracheostomies are more commonly performed in the critically ill patient to assist in long-term ventilatory support. Granulation tissue at the stoma and the trachea has been described as a late complication resulting in bleeding, drainage, and difficulty with maintaining mechanical ventilatory support. STUDY DESIGN: The present report is of an observational study of a newly implemented policy that required regular changing of tracheostomy tubes. Comparable groups of patients were compared before and after this procedural change to document complications. Data collection consisted of chart reviews of all admissions for 1 year before the policy change and the subsequent 2 years. Complication rates were compared using standard statistical techniques. METHODS: A policy change was instituted that required all tracheostomy tubes to be changed every 2 weeks in conjunction with a detailed evaluation of the tracheostomy stoma. Charts were reviewed the year before the change in policy and in the subsequent 2 years to determine the incidence of granulation tissue requiring operative intervention. RESULTS: The number of patients requiring surgical intervention secondary to granulation tissue showed a statistically significant decrease (P =.02). A review of policies and procedures from the six largest hospitals in southeastern Michigan had no recommendations for routine tracheostomy tube changes. CONCLUSIONS: A policy requiring a routine change of tracheostomy tubes results in fewer complications from granulation tissue. Tracheostomy tube changes to prevent granulation tissue and its complications.     

Influence of the roll compactor parameter settings and the compression pressure on the buccal bio-adhesive tablet properties

Miconazole buccal tablets were prepared via a dry granulation process. By applying a factorial design (2⁴), the roll compactor parameters (compaction force, gap between the rolls, type of the rolls (smooth, ribbed) and the sieve aperture) were optimised for the tablet strength. The compaction force and the roll type significantly affected the tablet strength. Afterwards, a quarter fractional factorial design (2^5-2) was applied, consisting of the four compactor parameters and additionally the compression pressure, in order to optimise these parameters for the dissolution profile and the buccal bio-adhesion characteristics (bio-adhesive force and energy). In order to evaluate the dissolution profiles properly, the similarity factor between sample and a zero-order release reference profile was used. The compression pressure and the roll type significantly affected the dissolution profile. The sieve aperture had a significant effect on the buccal adhesion properties and the compaction force had a significant effect on the dissolution profile and the bio-adhesive energy. The gap between the rolls affected the bio-adhesive force significantly.     

In-line monitoring of granule moisture in fluidized-bed dryers using microwave resonance technology

This is the first report on in-line moisture measurement of pharmaceutical products by microwave resonance technology. In order to meet the FDA’s PAT approach, a microwave resonance sensor appropriate for pharmaceutical use was developed and implemented into two different fluidized-bed dryers. The novel sensor enables a continuous moisture measurement independent from the product density. Hence, for the first time precise real time determination of the moisture in pharmaceutical granules becomes possible. The qualification of the newly developed sensor was performed by drying placebo granules under experimental conditions and the validation using drug loaded granules under real process conditions. The results of the investigations show good correlations between water content of the granules determined by the microwave resonance sensor and both reference methods, loss on drying by infrared light exposure and Karl Fischer titration. Furthermore, a considerable time saving in the drying process was achieved through monitoring the residual water content continuously by microwave resonance technology instead of the formerly used discontinuous methods.     

咽炎康颗粒制备工艺研究

为了优化咽炎康颗粒的制备工艺,采用正变试验法,以熊果酸、多糖等为指标,得出最佳的浸提工艺参数,同时考察了最佳的喷雾干燥及制粒条件．进而得出合理的颗粒制备工艺。     

Exploration of Novel Co-processed Multifunctional Diluent for the Development of Tablet Dosage Form

The aim of this investigation was to develop a novel multifunctional co-processed diluent consisting of microcrystalline cellulose (Avicel PH 102), crospovidone (Polyplasdone XL) and polyethylene glycol 4000. Colloidal silicon dioxide and talc were also incorporated as minor components in the diluent to improve tableting properties. Melt granulation was adopted for preparation of co-processed diluent. Percentage of Avicel PH 102, Polyplasdone XL and polyethylene glycol 4000 were selected as independent variables and disintegration time was chosen as a dependent variable in simplex lattice design. The co-processed diluent was characterised for angle of repose, bulk density, tapped density, Carr''s index, percentage of fines and dilution potential study. Acetaminophen and metformin were used as poorly compressible model drugs for preparation of tablets. The blend of granules of drug and extra-granular co-processed diluent exhibited better flow as compared to the blend of drug granules and physical mixture of diluents blend. The diluent exhibited satisfactory tableting properties. The tablets exhibited fairly rapid drug release. In conclusion, melt granulation is proposed as a method of preparing co-processed diluent. The concept can be used to bypass patents on excipient manufacturing.     

Monitoring of High-shear Granulation using Acoustic Emission: Predicting Granule Properties

Sound in the ultrasonic (20 to 1,000 kHz) range emitted during high-shear granulation was recorded and analyzed using multivariate techniques in order to assess the relationship between variations in the physical properties of the obtained granules and the evolution of acoustic emissions taking place during their formation. The acoustic signal analysis was preformed on two different granulators. A four-component model was obtained from the analysis and was capable of predicting the particle size distribution of the granules based on a 13 sieve cut measurement covering the range of 53–1,180 μm. The average error of prediction was less than 2%. Acoustic emission also proved useful as a predictor of granule moisture content. The final granule moisture content could be predicted with a root-mean-square error of prediction of 5.76% and 1.9% in the two different granulators evaluated in this investigation. The acoustic signals emitted during wet granulation contain the information necessary to make quantitative assessments of the changes in water content, particle size, and the particle size distribution of the granules produced by the process.     

慢性疮面之“去腐生肌”的再认识

“去腐生肌”具有独特临床疗效和鲜明中医特色,是慢性疮面治疗过程中的一种重要手段,但目前对“去腐生肌”的认识存在一定局限性且不全面。结合文献及临床实践,将“去腐生肌”重新定义为“去除一切阻碍疮面愈合的增多或新生病理产物,创造有利于或促进疮面愈合的疮面状态或新生产物的过程”。该定义全面考虑了去腐生肌所涉及的有形之腐和无形之腐、有形之肌和无形之肌之间的相互关系,并认为去腐与生肌之间存在“去腐生肌-肌生腐去-腐去肌生”这一动态过程,即去腐是生肌的必然条件,生肌是去腐的最终结果,临床中可依据具体情况选择不同的内治、外治手段来实现去腐和生肌。通过重新认识去腐生肌,以期为慢性疮面治疗提供新的思路。     

Initial moisture content in raw material can profoundly influence high shear wet granulation process

The aim of this work is to demonstrate that uncontrolled initial moisture content in microcrystalline cellulose (MCC) can profoundly affect high shear wet granulation (HSWG) process. We show that granule tabletability is reduced by approximately 50% when initial moisture content in MCC increases from 0.9% to 10.5% while all other processing parameters remain unchanged. An important observation is that granule tableting performance deteriorates significantly when initial moisture content increases from 2.6% to 4.9%, which is considered normal variation in moisture content for typical MCC (3-5%). The deteriorated tabletability is largely caused by increased granule size. On the other hand, granule flowability improves continuously with increasing initial moisture content in MCC. The improved flowability is mainly a result of granule size enlargement. Clearly, moisture content of raw materials for a HSWG process must be carefully monitored and controlled to ensure a robust manufacturing process as required by the quality-by-design principle.     

紫外分光光度法测定烟酸微丸中烟酸的含量

目的：测定烟酸微丸中烟酸的含量。方法：采用离心造粒法制备烟酸含药微丸,利用紫外分光光度法建立烟酸的含量测定方法。结果：在2.0-20.0μg.m l^-1范围内,线性关系良好,平均回收率为98.5%,RSD%小于2.5%,烟酸微丸的含药量为70.6%。结论：采用紫外分光光度法测定烟酸含量方法准确、操作简便,快速,重现性好。