Miyazaki Yasunori, Uchino Tomonobu, Kagawa Yoshiyuki
Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences, University of Shizuoka.
Chem Pharm Bull (Tokyo). 2014;62(5):488-90. doi: 10.1248/cpb.c14-00020.
We developed a color difference signal method to evaluate the degree of blending powdered medicines in pharmacies. In the method, the degree of blending is expressed as the relative standard deviation of the color difference signal value (Cb or Cr) of the YCbCr color space after digital photos of the blended medicines are analyzed by image processing. While the method is effective to determine the degree of blending colored medicines, it remains unknown whether it can be applied to uncolored or white-colored medicines. To investigate this, we examined colored diluents to identify an indicator of the degree mixtures are blended. In this study, we applied this method to Pontal® and Prednisolone® powders, which were used as uncolored and white-colored medicines, respectively. Each of these medicines was blended with the colored lactose using a pestle and mortar, and then the uniformity of blending was evaluated. The degree of blending was well-monitored in both mixtures with various blending ratios (1 : 9-9 : 1), showing a sufficient uniformity at 60 rotations of the pestle. Moreover, the Cr values of the mixtures with various blending ratios were correlated with the concentration of active pharmaceutical ingredients in these medicines, which was determined using HPLC. This indicated the usefulness of the color difference signal method for the quantitative determination of medicines. Thus, we demonstrated the applicability and effectiveness of this method to check dispensing powders.
我们开发了一种色差信号方法来评估药房中粉状药物的混合程度。在该方法中，混合程度表示为通过图像处理对混合药物的数码照片进行分析后，YCbCr颜色空间中色差信号值（Cb或Cr）的相对标准偏差。虽然该方法在确定有色药物的混合程度方面有效，但它是否可应用于无色或白色药物仍不清楚。为了研究这一点，我们研究了有色稀释剂以确定混合物混合程度的指标。在本研究中，我们将该方法应用于分别用作无色和白色药物的泮托拉唑®和泼尼松龙®粉末。将每种药物与有色乳糖在研钵中混合，然后评估混合的均匀性。在具有各种混合比例（1∶9至9∶1）的两种混合物中，混合程度均得到了良好监测，在研杵旋转60次时显示出足够的均匀性。此外，具有各种混合比例的混合物的Cr值与使用高效液相色谱法测定的这些药物中活性药物成分的浓度相关。这表明色差信号方法在药物定量测定中的有用性。因此，我们证明了该方法在检查调配粉末方面的适用性和有效性。
