多维片处方研究及工艺探讨

采用单因素试验设计,以溶出度和崩解度为评价指标,筛选多维片处方和工艺,并对其进行稳定性考察。试验结果表明,所制得的片剂释放迅速而且完全,质量稳定,该工艺能够有效地解决多雏片的崩解度和VC含量降解的问题。     

棉子饼粕在鱼饲料中的应用

介绍了棉子饼及由棉子粕发酵制成的多维菌体蛋白粉在鱼饲料中的添加比例及应用效果。     

同位素稀释-超高压液相色谱-串联质谱法测定 维生素营养液中的泛酸含量

目的 建立测定维生素营养液中泛酸含量的同位素稀释-超高压液相色谱串联质谱法(ID-UHPLC-MS/MS)。方法 样品经高氯酸水溶液涡旋提取和除杂、超纯水稀释后,以HSS T3色谱柱和0.1%(v/v)甲酸水溶液-乙腈进行梯度洗脱分离,以串联质谱的多反应监测模式检测,内标法定量。结果 泛酸在5 ~1000 μg/L范围内具有良好的线性关系,相关系数(R₂)为0.9998;方法检出限为0.02 mg/100 g,定量限为0.07 mg/100 g;3个添加水平的回收率为92.5%~103%,相对标准偏差(n=6)为2.3%~5.2%;日间相对标准偏差(n=3)为2.72%。结论 本方法操作简便、分析速度快、灵敏度高、重复性好,为维生素营养液中泛酸含量的定性定量分析提供了可靠的依据。     

高效液相色谱法测定复合维生素片中维生素D3含量的不确定度评定

目的评定高效液相色谱法(high performance liquid chromatography,HPLC)测定复合维生素片中维生素D_3含量的不确定度。方法依据国家计量技术规范JJF 1059.1—2012《测量不确定度评定与表示》对维生素D_3测定中的不确定度来源进行分析。通过建立数学模型量化不确定度分量,计算合成不确定度和扩展不确定度。结果本方法的不确定度主要来源于标准曲线的拟合、重复性试验和回收率实验。样品中维生素D_3含量以其扩展不确定度的形式表示为(260±12.7)μg/100 g(k=2)。结论该评定方法可用于高效液相色谱法对复合维生素片中维生素D_3的不确定分析。     

反相离子对色谱法同时测定饲料中多种水溶性维生素

本文首次提出一种简便、快速地同时测定配合饲料中多种水溶性维生素的反相离子对HPLC方法。此方法用合适的波长和灵敏度程序检测,以抑制和排除杂质峰的干扰;在样品预处理上,采取特殊措施以防止维生素的分解,减少杂质含量。     

Preformulation: Effect of Moisture Content on Microcrystalline Cellulose (Avicel PH-302) and Its Consequences on Packing Performances

This study evaluates the influence of moisture content on the packing performances of a new grade of microcrystalline cellulose (MCC) (Avicel PH-302) either by classical method or by an unconventional compression technique (constant volume reduction of powder bed). An increase in moisture content decreases the apparent density of the powder bed, resulting from interparticulate friction enhancement. This modification of apparent density seems to be the main effect caused by the presence of humidity, which explains the variations of compression properties, like an increase of powder plasticity generally observed in the experimental conditions.     

Analytical capability of a medium power capacitively coupled plasma for the multielemental determination in multimineral/multivitamin preparations by atomic emission spectrometry

A method for multielemental (Ca, Cr, Cu, Fe, K, Mg, Mn, Na, P and Zn) determination in multimineral/multivitamins by atomic emission spectrometry in a medium power radiofrequency capacitively coupled plasma (275 W) and low Ar consumption (0.4 L min⁻¹) is proposed. Determinations were performed on commercially available tablets and a standard reference material after acidic high-pressure microwave assisted digestion and using the standard additions procedure. The detection limits (mg g⁻¹) were in the range 0.003 (Na)–1.5 (P) and were not depreciated by the non-spectral interference of mineral matrices of K, Ca, Mg and Na excepting Zn and P. Found concentrations corresponded generally to the labelled contents with recovery in the range of 90–107% and 1.0–13.0% repeatability. The proposed technique could be an advantageous alternative to the more expensive inductively coupled plasma atomic emission spectrometry in the quality control of multimineral/multivitamin preparations.     

高效液相色谱法快速测定多维片中的维生素B12

目的建立高效液相色谱法快速测定多种维生素片中的维牛素B_(12)含量。方法样品用水作为溶剂经超声波提取,以0.02 mol/L磷酸二氢钾溶液(pH=2.5)和乙腈作为流动相采用高效液相色谱法测定,以外标法定量。结果本研究将检测波长改为546 nm,可减少多维片中其他组分的干扰。维生素B_(12)在0.5~10 mg/L范围内线性关系良好(r=0.9999),在1、2和5 mg/L的添加水平下测得回收率分别为98.1%、97.2%和99.0%(n=6),相对标准偏差分别为3.6%、2.0%和4.6%,方法检出限为0.2 mg/L,定量限为0.5 mg/L。结论该方法快速、简便、准确且干扰少,可适合于多种维生素片中维生素B_(12)的定量分析。     

Characterization of excipient and tableting factors that influence folic acid dissolution, friability, and breaking strength of oil- and water-soluble multivitamin with minerals tablets

The goal of this study is to characterize the formulation and processing factors that influence folic acid dissolution from oil- and water-soluble multivitamin with minerals tablet formulations for direct compression. The following parameters were studied: bulk filler solubility, soluble to insoluble bulk filler ratio, triturating agent (preblending carrier) solubility, disintegrant usage, compression pressure, and folic acid particle size. Folic acid particle size was determined by using light microscopy, and surface area was measured by using BET adsorption. The tablets were compressed on an instrumented Stokes B2 tablet press, and the friability, weight variation, and dissolution were measured according to USP methods, along with tablet breaking strength. In summary, we found the following factors to be critical to folic acid dissolution: bulk filler solubility (soluble fillers, such as maltose, increase folic acid dissolution); disintegrant amount (levels less than 0.4% (w/w) are ineffectual, whereas levels greater than 1.2% (w/w) did not further increase dissolution); and compression force (generally, maltose produce harder tablets). In addition, folic acid dissolution was less affected by changes in compaction pressure when a “super” disintegrant and maltose, as a bulk filler, were used. It was determined that the trituration agent did not play a significant role in folic acid dissolution. In the range of parameters studied, statistical analysis found no significant interactions between the parameters studied, which means they act independently in an additive manner. The results also show that no one factor is completely responsible for dissolution failure. Thus, it is the combination of formulation factors and processing conditions that collectively add up to produce dissolution failure; however, the use of a disintegrant and a soluble filler such as maltose can make a formulation more robust to the inevitable changes that can occur during commercial production.