摘要
目的:按照2020版《中国药典》四部通则《原料药物与制剂稳定性试验指导原则》规定,对研制出的凉粉草降糖颗粒进行影响因素试验、加速试验和长期试验等稳定性试验,为药品的生产、包装、贮存、运输条件提供科学依据[1],同时通过试验建立凉粉草降糖颗粒的有效期。结果:凉粉草颗粒的外观性状、水分、鉴别及含量测定等检查结果与0月相比无明显变化,说明该制剂的性质较稳定,包装材料对制剂性质无影响。结论:根据以上试验的结果,凉粉草颗粒应在密封、防潮、阴凉、干燥等条件下储存,有效期可暂定为12个月[2]。
Objective:In accordance with the Guiding Principles for the Stability Test of Raw Materials Drugs and Preparations in the fourth General rule of the 2020 edition of the Chinese Pharmacopoeia,stability tests such as influencing factor tests,accelerated tests and long-term tests are carried out on the developed Mesona chinensis Benth granules to provide a scientific basis for the production,packaging,storage and transportation conditions of drugs.Meanwhile,the validity period of Mesona chinensis Benth granules was established through experiments.Results:The results of appearance,moisture,identification and content determination of Mesona chinensis Benth granules showed no significant changes compared with O months,indicating that the properties of the preparation were stable,and the packaging materials had no influence on the properties of the preparation.Conclusion:According to the results of the above tests,Mesona chinensis Benth granules should be stored under sealed,moisture-proof,cool and dry conditions,and the validity period can be tentatively set as 12 months.
作者
冯白茹
Feng Bairu(Huizhou Health Sciences Polytechnic,Huizhou 516025,China)
出处
《山东化工》
CAS
2024年第10期158-161,共4页
Shandong Chemical Industry
基金
2022年度惠州市医疗卫生领域科技计划项目(2022CZ010208)。
关键词
凉粉草
颗粒
稳定性
Mesona chinensis Benth
granules
stability
