细辛脑吸入气雾剂的制备和质量控制

Preparation and Quality Control of Asarone Inhalation

目的考察气雾剂中不同药物浓度对肺部药量和物理稳定性的影响,获得处方中最佳细辛脑浓度,并建立其质量控制方法。方法采用双级液体碰撞器(TSI)测量其雾滴分布(FPF)和紫外分光光度法(UV)测定每揿药物含量,筛选出配方中细辛脑的最佳比例,同时以细辛脑为主药,制备细辛脑吸入气雾剂,用紫外分光光度法测定其含量,进行质量控制。结果制备7.4%细辛脑吸入气雾剂泄露率低,每揿含量均一,质量稳定。结论该吸入气雾剂制备工艺简单,性质稳定,质量可控。

OBJECTIVE To investigate the effects of drug content on the pulmonary dosage and physical stability of aerosol pressure metered-dose inhalations,so as to determine the optimal drug content in the formulation,and to construct its quality control method. METHODS Asarone was used as the model drug to prepare pressure metered-dose inhalations. The fine particle fraction was measured by twin stage impinger. The drug content in each press was determined by UV measurement. A method was developed to evaluate and control the quality of the preparations. RESULTS The Asarone inhalation with the optimal drug content of 7.4% showed a low leakage rate,good content uniformity in each press,and good physical stability. CONCLUSION A simple,stable,and quality controllable Asarone inhalation has been successfully prepared.