复方薄荷脑滴鼻液配制工艺改进前后的质量研究  

Quality Study of Compound Menthol Nasal Drops Before and After Preparation Process Improvement

作　　者：方水凉[1] 邱杏桃[1] 赵海瑛 FANG Shuiliang;QIU Xingtao;ZHAO Haiying(Department of Pharmaceutical Preparation,the First Affiliated Hospital of Xiamen University,Xiamen Fujian 361003,China;Department of Pharmacy,Fujian University of Traditional Chinese Medicine,Fuzhou Fujian 350108,China)

机构地区：[1]厦门大学附属第一医院制剂科,福建厦门361003 [2]福建中医药大学药学系,福建福州350108

出　　处：《中国卫生标准管理》2023年第6期140-147,共8页China Health Standard Management

摘　　要：目的通过对工艺改进前后之复方薄荷脑滴鼻液的配制方法与配制时间的比较并对成品质量进行研究,考察新工艺下配制复方薄荷脑滴鼻液的质量是否符合药用标准,配制方法是否高效。方法改进原工艺,采用先配制低共熔混合物再加入液状石蜡的配制方法,通过与原工艺下复方薄荷脑滴鼻液的配制时间进行对比,考察新工艺是否高效,并根据福建省医疗机构制剂规程第十一批发布标准和《中华人民共和国药典》2020版对鼻用制剂的相关要求,对原工艺和新工艺下配制的复方薄荷脑滴鼻液的性状、成份鉴别、相对密度,微生物限度检测4个方面进行考察,以研究新工艺下配制的复方薄荷脑滴鼻液的质量是否稳定。结果在新工艺下,樟脑、薄荷脑形成的低共熔混合物完全液化,能迅速溶解于液状石蜡中,且复方薄荷脑滴鼻液的性状、成份鉴别、相对密度及微生物限度检测,符合标准要求。结论利用薄荷脑和樟脑形成低共熔混合物的原理改进原工艺配制复方薄荷脑滴鼻液的质量研究,质量稳定,方法可行,且新工艺下的配制方法能有效缩短复方薄荷脑滴鼻液的配制时间,提高生产效率,适合批量生产。Objective By comparing the preparation method and preparation time of compound menthol nasal drops before and after the process improvement and studying the quality of finished products,the quality of compound menthol nasal drops prepared by the new process was investigated whether the quality of compound menthol nasal drops met the medical standards and whether the preparation method was efficient.Methods To improve the original technology,the first-made eutectic mixture was used again to join the preparation method of liquid paraffin,through with the original process of compound menthol nasal drops,comparing the preparation time of new process is efficient,and according to the rules of preparations of medical institutions in fujian province in batch release 11 standard and the law of the People's Republic of China pharmacopoeia 2020 edition of nasal preparation requirements,the properties,component identification,relative density and microbial limit detection of compound menthol nasal drops prepared by the original process and the new process were investigated to study whether the quality of compound menthol nasal drops prepared by the new process was stable.Results Under the new process,the eutectic mixture formed by camphor and menthol was completely liquefied and could quickly dissolved in liquid paraffin.The properties,component identification,relative density and microbial limit detection of compound menthol nasal drops meet the standard requirements.Conclusion The quality of compound menthol nasal drops was improved by using the principle of low eutectic mixture formed by menthol and camphor.The quality was stable,the method was feasible,and the preparation method under the new process could effectively shorten the preparation time of compound menthol nasal drops,improve the production efficiency,and was suitable for mass production.

关 键 词：复方薄荷脑滴鼻液 低共熔 工艺改进 质量研究 薄层色谱 微生物限度检测 

分 类 号：R994[医药卫生—毒理学]