激光散射法测定那他霉素粒度研究

为了减少那他霉素原料药各批次之间的粒度差异，提高其制剂产品质量和疗效稳定性,建立了一种激光散射法测定那他霉素粒度的方法。采用Mastersizer 2000激光粒度仪干法测定那他霉素粒度，分别对分散气压、振动进样速度及测量时间等关键测定参数进行了优选，并对本方法的重复性、中间精密度和耐用性进行了验证。结果表明：在分散气压为0.30 MPa、振动进样速度为45%、背景和测量扫描时间为10 s、样品折射率为1.50、颗粒吸收率为0.1、遮光度范围为0.5%~5%等条件下，所测样品的RSD均小于2.5%。方法学各项验证指标相对标准偏差均符合要求。所建立的测定那他霉素粒度的激光散射法精密度较高、重复性好，能够有效控制原料药的批间差异，可为生产出安全、有效、均一、稳定的制剂产品提供保障和参考。HJ4mm]

Study on the particle size determination of natamycin by laser scattering

In order to reduce the particle size difference between batches of natamycin, improve the quality and efficacy stability of the drug products, a laser scattering method was established using Mastersizer 2000 laser particle size analyzer to determine the particle size of natamycin by dry method. The key measurement parameters such as dispersion pressure, vibration injection speed, and determination time was optimized. And the repeatability, intermediate precision, and durability of this method were verified. The results show that under the conditions of dispersion pressure of 030 MPa, vibration injection speed of 45%, background and determination scanning time of 10 seconds, sample refractive index of 150, particle absorption index of 01, and opacity range of 05%~5%, the RSD of the measured samples are all less than 25%, and the relative standard deviation of various validation indicators in methodology meets the requirements. The established laser scattering method for determining the particle size of natamycin has high accuracy and good repeatability, which can effectively control the inter batch differences of raw materials and provide guarantee and reference for the production of safe, effective, uniform, and stable pharmaceutical products.