RESUMO
Objective To provide theoretical reference and practical basis for accurately choosing the suitable packaging forms for different Injections. Methods Based on the raw materials in the common packaging forms of injections, the research and application progress on different packaging forms for injections were reviewed by analyzing the characteristics and technical requirements of different packaging forms, and the current registration information of pharmaceutical packaging materials in the Center for Drug Evaluation, NMPA were introduced. Results For preparations with small single-dose and low-cost, the ampoules or injection vials could be chosen. Powder injections are usually packaged in injection vials. For rescue medicines and valuable medicines, the pre-filled syringes could be chosen. For chronic disease treatment drugs (such as insulin) that require long-term injection, or some injections for emergency use, a pen-type syringe package that patients can inject themselves could be used. Neutral glass packaging or plastic packaging should be used for some acidic or alkaline. Conclusion The drug manufacturers should comprehensively consider the physicochemical properties of drugs, the performance of packaging raw materials, compatibility test results, price-cost, and convenience in carrying and use when choosing the appropriate packaging form to ensure the quality, safety, and effectivity of drugs.
RESUMO
Objective To establish a fast detection method of sodium aescinate by using near infrared (NIR) spectroscopy analysis method for the determination of the content of sodium aescinate for injection. Methods OPUS software was used to optimize the collected spectrum. PLS algorithm and factorization algorithm were used to establish quantitative model and qualitative model. Results The correlation coefficient of the quantitative model reached 0.9926, the RMSECV deviation was 0.253. The deviation between the predicted value of the sample and the true measured value was less than 5%, which could accurately predict the content of sodium aescinate. Conclution The qualitative model can effectively distinguish the samples of other varieties that have not participated in the modeling, and provide a reference for the rapid screening of the drug.
RESUMO
To ensure the safety and efficacy of the military thermo-sensitive drugs, it is necessary to monitor the temperature changes through the whole process of production, transportation, storage, distribution and application. The characteristics of various commercial TTI were analyzed. The applications of TTI technology in the quality control for military thermo-sensitive drugs were reviewed in order to provide accurate quality assurance for those drugs.