Effect of preparation method on compactability of paracetamol granules and agglomerates

The objective of this study was to investigate the effect of fracture strength of paracetamol particles on their compactability. For this purpose two series of paracetamol particles were prepared by crystal agglomeration and by granulation using different solvents. A free flowing particle size fraction of all types of particles was characterized with respect to their shape, degree of agglomeration and single fracture strength. The powders were compressed to tablets and the compression mechanism of the particles and the evolution in tablet micro-structure were assessed by compression parameters derived from the Heckel and Kawakita equations and by a tablet permeabililty coefficient. Tablet tensile strength and porosity were determined. The degree of deformation and fragmentation during compression varied between agglomerates and granules and was dependent on their failure strength. The granules varied in compactability with particle failure strength while the agglomerates showed limited variation. It is proposed that, the dominant mechanism of compression for the granules was permanent deformation while for the agglomerates it was fragmentation. It was thus found that the compression mechanism of the particles was dependent on both the degree of agglomeration and the particle failure strength.     

高剪切方法制备穿心莲干浸膏颗粒的影响因素考察

目的以3批流动性不同的穿心莲干浸膏为模型药,研究高剪切方法在制粒过程中的主要影响因素。方法分别以3批穿心莲干浸膏为原料,以颗粒粒径分布及各粒径范围内脱水穿心莲内酯含量分布的相对标准偏差(RSD%)为指标,对高剪切制粒过程中黏合剂用量、搅拌桨转速及制粒时间进行三因素两水平完全析因设计实验。结果黏合剂用量及制粒时间对3批流动性不同穿心莲干浸膏制得颗粒的几何平均粒径均有显著影响;流动性较差穿心莲干浸膏进行高剪切制粒时,最终颗粒群中脱水穿心莲内酯含量均匀度受搅拌桨转速影响程度最大;浸膏流动性不同,三因素之间交互作用有所不同。结论控制高剪切制粒过程的技术参数,可以改善流动性不同的中药浸膏制得颗粒的粒径分布及含量均匀度。     

非洛地平缓释微丸的制备

目的制备非洛地平缓释微丸。方法采用离心造粒法,在离心造粒机内通过制备母核、制备含药微丸、包衣3步完成。结果释放度符合缓释要求,工艺重现性好。结论离心造粒法可用于制备非洛地平缓释微丸。     

Incidence and possible pathogenesis of sentinel node micrometastases in ductal carcinoma in situ of the breast detected using molecular whole lymph node assay

Background:

The pathogenesis of lymph node metastases in preinvasive breast cancer – ductal carcinoma in situ (DCIS) – remains controversial. The one-step nucleic acid amplification (OSNA) assay is a novel molecular method that can assess a whole node and detect clinically relevant metastases. In this retrospective cohort study, we determined the performance of the OSNA assay in DCIS and the pathogenesis of node-positive DCIS.

Methods:

The subjects consisted of 623 patients with DCIS who underwent sentinel lymph node (SN) biopsy. Of these, 2-mm-sectioned nodes were examined using frozen-section (FS) histology in 338 patients between 2007 and 2009, while 285 underwent OSNA whole node assays between 2009 and 2011. The SN-positivity rate was compared between cohorts, and the characteristics of OSNA-positive DCIS were investigated.

Results:

The OSNA detected more cases of SN metastases than FS histology (12 out of 285, 4.2% vs 1 out of 338, 0.3%). Most of the metastases were micrometastases. The characteristics of high-risk DCIS (i.e., mass formation, size, grade, and comedo) and preoperative breast biopsy (i.e., methods or time to surgery) were not valid for OSNA assay–positive DCIS.

Conclusion:

The OSNA detects more SN metastases in DCIS than FS histology. Further examination of the primary tumours and follow-up of node-positive DCIS are needed to elucidate the pathogenesis.     

干湿法制粒技术在片剂生产中的对比应用

目的通过对不同制备工艺制得的曲克芦丁片(以下简称QK片)和复合磷酸酯酶片(以下简称FM片)进行比较,对两种片剂的制备工艺进行调整。方法采用湿法制粒工艺(以下简称SF工艺)和干法制粒工艺(以下简称GF工艺)分别制备QK片和FM片各三批,并对所制得的颗粒进行粒径分布、休止角、颗粒流动性、可压性、含量和效价测定及六个月的稳定性加速实验数据分析和比较。结果与SF工艺相比,GF工艺虽然在颗粒流动性和可压性方面相对不足,却可以明显提高某些热不稳定品种(如FM片)的稳定性。结论GF工艺技术作为近年来在国际上发展起来的新型造粒技术,在很多方面较SF工艺有着一定的优势,加上通过适当调整生产处方中辅料的用量,使其能够得到较为广泛的应用。     

基于流化床顶喷技术的巴戟天寡糖胶囊成型工艺研究

目的采用流化床顶喷制粒技术优化和建立中药巴戟天寡糖颗粒一次成型的工艺路线和工艺参数。方法采用单因素考察法,设定流化床顶喷包衣锅的主要工艺参数范围,将巴戟天水提取物喷至一定量的微晶纤维素粉末上,制备巴戟天寡糖颗粒,并分别测定其休止角、抹角、松密度、轻敲密度、压缩度和均一度等,计算流动性指数和平均粒径。结果当进风温度设定为40～45℃;进风压力设定为0．35～0．45bar;雾化压力设定为1．5～2．0bar;喷液速率设定为15～25r·min^-1范围时,制备的巴戟天寡糖颗粒可顺利灌装装量均一的胶囊。结论该工艺使制剂一次成型,具有生产周期短、生产效率高、辅料用量小和产品成本低等优点,在中药制剂的成型工艺中值得推广应用。     

颅骨蛛网膜颗粒压迹的MRI表现

目的探讨颅骨蛛网膜颗粒压跡的MR I影像特点及诊断价值。方法回顾性分析38例典型颅骨蛛网膜颗粒压跡MR I影像特点。结果 38例中发现蛛网膜颗粒压跡105个蛛网膜颗粒,上矢状窦內发现蛛网膜颗粒78个,15例橫窦24个,直窦及窦汇和下矢状窦各1例共发现3个。15例行MRV中可见靜脉窦充盈缺损45个,MR均表现为长T1长T2信号。结论蛛网膜颗粒是一种正常解剖结构,通常与临床表现无关,有影像学特征表现。     

自体颗粒脂肪移植充填矫治面部凹陷

目的：观察自体脂肪移植充填矫治面部凹陷的临床效果。方法：在肿胀麻醉下，利用注射器抽吸脂肪颗粒。过滤纯化后将脂肪颗粒注射在面部凹陷部位。结果：采用自体脂肪颗粒移植矫正面部凹陷153例，注射1～3次均获良好效果。结论：利用自体脂肪移植充填矫治面部凹陷是一种理想的方法。     

枕骨蛛网膜颗粒隐窝的影像诊断

目的:探讨枕骨蛛网膜颗粒隐窝的CT、MR表现及其诊断价值.方法:回顾性分析1996年以来收治的23例枕骨蛛网膜颗粒隐窝的CT及MR影像特点.结果:23例枕骨蛛网膜颗粒隐窝均位于枕骨粗隆下方,CT表现为穿凿样骨质缺损,深达板障或外板,境界清锐.骨质缺损区横径为7～30 mm(最大者为双侧对称性生长,各侧均为25 mm×30 mm).8例MR显示内部信号均匀、且在各个序列上与脑脊液信号一致.3例钆喷替酸葡甲胺(Gd-DTPA)增强后均未见病灶强化.结论:蛛网膜颗粒隐窝是一种正常变异,通常与临床表现无关,有影像学特征表现.认识其CT、MR特征表现对与枕骨破坏性病变的鉴别非常重要.