气流筛分技术在蒲黄除杂工艺中的应用研究

Study on application of airflow screening technology in purification process of Pollen Typhae

运用气流筛分技术对蒲黄进行除杂,气流筛下产品按《中华人民共和国药典》要求分别进行杂质率检测、显微定性鉴定、显微计数鉴定、灰分测定、酸不溶性灰分测定、含量测定;同时将新工艺与传统工艺进行综合对比,从耗损率、收率、筛料时间、单位时间筛料量和扬尘等指标进行考察。对筛下成品进行7项指标综合评定,采用气流筛分技术过9号筛的产品均能达到2010年版《中华人民共和国药典》规定的各项质量标准与要求。将气流筛分技术运用到蒲黄除杂工艺中,能够解决蒲黄筛分效率低、筛下成品质量不稳定和扬尘的问题,达到优化蒲黄除杂工艺之目的,符合新版药品生产质量管理规范(GMP)的洁净要求,有利于实现蒲黄饮片的工业化生产。

The airflow screening technology was applied in the purification process of Pollen Typhae, the impurity detection, microscopic qualitative identification, microscopic count identification, ashes determination, determination of acidinsoluble ash content, and content determination were carried out respectively based on products screened by airflow according to the requirements of Pharmacopeia of People,s Republic of China. Meanwhile, the new technology was compared with the traditional technology based on the indicators as losses coefficient, yield coefficient, time of screening, screening yield in unit time, and raise dust. The 7 indicators of products screened by airflow screening technology were evaluated synthetically, and the products screened by the No. 9 sifter could meet the quality standard and requirements stipulated in Pharmacopeia of People,s Republic of China（2010 version）. The airflow screening technology applying in the purification process of Pollen Typhae could solve the problems as low screening efficiency, unstable quality of finished products, and raise dust, and optimize the purification process of Pollen Typhae. This technology met the cleanliness requirements of new GMP, and was beneficial to industrialized production of Pollen Typhae.