Yu Jia-Qi, Xu Bing, Huang Yu-Yan, Zhang Zhi-Qiang, Dai Sheng-Yun, Fu Jing, Qiao Yan-Jiang
Department of Chinese Medicine Information Science, Beijing University of Chinese Medicine Beijing 102400, China.
Department of Chinese Medicine Information Science, Beijing University of Chinese Medicine Beijing 102400, China Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine, Beijing Municipal Science & Technology Commission Beijing 102400, China.
Zhongguo Zhong Yao Za Zhi. 2020 Jan;45(2):259-266. doi: 10.19540/j.cnki.cjcmm.20191219.304.
In this paper, the inline turbidity sensor technology was used to quantify the turbidity of the solution during the dissolution of Chinese medicine granules. The probe measurement position and the magnetic stirring speed were optimized. As a result, the stirring speed was 400 r·min~(-1), and the probe position was at 1/4 of the diameter of the beaker. The measurement results were accurate and reliable. Totally 105 batches of commercially available Chinese medicine granules were collected and dissolved according to the requirements of the Chinese Pharmacopoeia. At the time point of 5 min, 57 batches of granules were completely dissolved, and the corresponding turbidity values ranged between 0-70 FTU; 32 batches of granules showed a slight turbidity, and the corresponding turbidity values ranged between 70-350 FTU; 14 batches of granule solution were turbid, and the corresponding turbidity values ranged between 350-2 000 FTU; two batches of granule solution were heavily turbid, and the corresponding turbidity values were >2 000 FTU. Among the above results, the number of batches in line with the pharmacopoeia dissolution requirement was 84.76%, and the dissolution of some granules still needed to be improved. The turbidity sensor recorded the change curve of turbidity value over time(solubility behavior curve). The degree of important of disintegration and dissolution during the dissolution process showed disintegration > dissolution, disintegration≈dissolution, disintegration < dissolution. The dissolution behavior of the granules can be classified into three categories. The analysis of the mechanism in the process of granule solubility provides a basis for product process improvement.
本文采用在线浊度传感器技术对中药颗粒溶出过程中溶液的浊度进行量化。对探头测量位置和磁力搅拌速度进行了优化。结果表明，搅拌速度为400 r·min⁻¹，探头位置为烧杯直径的1/4处。测量结果准确可靠。共收集105批市售中药颗粒，并按照《中国药典》要求进行溶出。5分钟时间点，57批颗粒完全溶解，相应浊度值在0 - 70 FTU之间；32批颗粒出现轻微浑浊，相应浊度值在70 - 350 FTU之间；14批颗粒溶液浑浊，相应浊度值在350 - 2000 FTU之间；2批颗粒溶液严重浑浊，相应浊度值>2000 FTU。上述结果中，符合药典溶出要求的批次占84.76%，部分颗粒的溶出仍有待提高。浊度传感器记录了浊度值随时间的变化曲线（溶解度行为曲线）。溶出过程中崩解与溶出的重要程度表现为崩解>溶出、崩解≈溶出、崩解<溶出。颗粒的溶出行为可分为三类。对颗粒溶解过程中机制的分析为产品工艺改进提供了依据。
