CAJ | 학술논문

目的：验证探讨乙醇灭菌方法对中药固体制剂灭菌效果。方法按中国药典2010版一部，药品微生物限度检查法规定，对总计约30个批次的品种进行乙醇蒸汽灭菌效果评价。结果饮片合格率为90%，粉末合格率为38%，成品合格率为62%。结论乙醇蒸汽灭菌方法可行，灭菌效果明显。但饮片灭菌后的后续粉碎、制剂过程需进一步完善，强化净化管理，才能保证最终成品合格。
목적：험증탐토을순멸균방법대중약고체제제멸균효과。방법안중국약전2010판일부，약품미생물한도검사법규정，대총계약30개비차적품충진행을순증기멸균효과평개。결과음편합격솔위90%，분말합격솔위38%，성품합격솔위62%。결론을순증기멸균방법가행，멸균효과명현。단음편멸균후적후속분쇄、제제과정수진일보완선，강화정화관리，재능보증최종성품합격。
Objective Validation to investigate ethanol sterilization method on the sterilization effect of solid preparations of Chinese medicine. Methods 30 Chinese patent medicine preparations were col ected and sterilized by ethanol vapor sterilization. The effects of sterilization were evaluated with microorganism limited inspecting method of" Chinese Pharmacopoeia" 2010 version Part One. Results The decoction pieces qualification rate is 90%, the powder qualification rate is 38%, the finished products qualification rate is 90%. Conclusion The ethanol vapor sterilization of TCM is an effective sterilization method. In order to ensure that the passing rate of finished products, during crushed and preparations after sterilization for decoction pieces stil need further perfect, intensify the management of purification.