Study On Compatibility Of Astragalus And Sodium Chloride Injection And Polypropylene Infusion Bottle

Astragalus injection is a commonly used traditional chinese medicine preparation.Astragalus and sodium chloride injection is a large-capacity injection developed based on the prescription of astragalus injection in accordance with convenient clinical needs.At present,no large-volume injection of astragalus has been approved for marketing in china.Astragalus is the main component in astragalus and sodium chloride injection,Sodium chloride as an isotonicity regulator.Astragalus has various pharmacological effects,it has a positive inotropic effect on cardiovascular,has a good protective effect on ischemic and hypoxic myocardium and virus infected myocardium,and has a strong regulation effect on blood pressure and blood glucose.Pharmaceutical packaging materials refer to pharmaceutical-grade packaging materials that come into direct contact with pharmaceutical products.Pharmaceutical packaging materials are one of the key components of medicines.The choice of pharmaceutical packaging materials must take into account the properties of drug storage,transportation,and use,to protect the quality,safety and effectiveness of medicines.The study of the compatibility of pharmaceutical packaging materials and drugs has a crucial impact on the quality of drugs.The choice of additives in the pharmaceutical packaging material will affect its stability.After the drug is in direct contact with the packaging material,over time and changes in external conditions may migrate into the drugsolution,reduce the quality of the drug,and even cause toxic reactions.Packaging materials are not only an important part of the drug quality system,but also an important guarantee for the safety and effectiveness of the drug during its life cycle.Therefore,research on the compatibility of drugs with selected drug packaging materials becomes particularly important.Astragalus and sodium chloride injection uses polypropylene infusion bottle as the direct contact inner packaging material.Polypropylene infusion bottle consists of two parts: infusion bottle and combined cap.Based on the formula information of the two parts of the component,the research object is determined as antioxidant 168,antioxidant 1010,magnesium and aluminum in hydrotalcite.Extraction studies were performed on additives in polypropylene infusion bottles to identify targets that may migrate into astragalus and sodium chloride injection,and migration studies were performed to determine the amount of migration into the drug solution.In accordance with the guidelines for drug compatibility testing,a migration trend of the target was studied by the stability test to determine the migration of each component added to the astragalus and sodium chloride injection.The extraction and migration test content determination method has been verified by a comprehensive analysis method,the verification indicators include linearity test,detection limit test,limit of quantificationtest,precision test,accuracy test,solution stability test,etc.It is determined that the method used is suitable for the determination of the additives.According to the above research,it was found that the polypropylene infusion bottle was selected as the inner contact material for direct contact with astragalus and sodium chloride injection,and its physical and chemical properties did not change significantly,indicating that had good compatibility.This development is a large-capacity injection of astragalus and sodium chloride injection.According to the convenience of clinical needs,avoid opening the glass ampoule to scratch the hand and the glass particles to contaminate the drug during clinical preparation of the small-volume injection,resolved possible compatibility issues with thinners,rapid clinical medication can be used for direct infusion without drug preparation conditions,the polypropylene infusion bottle is selected as the inner packaging material,which has the advantages of low cost,good stability,non-fragility and safety.It provides reliable data support for the selection of inner packaging materials of drugs,and provides scientific basis for ensuring the safety,effectiveness and quality controllability of drugs.