Preparation And Freeze-drying Technology Of Antibiotic Drugs
Several aspects that need to be known when preparing and lyophilizing antibiotics:
1. The water temperature of the ingredients, the order of adding the ingredients, the adsorption time and temperature of the activated carbon, and the storage time of the feed liquid.
2. Some raw materials have polymorphic forms, and the stability of different crystal forms is different; some raw materials are sensitive to temperature; some raw materials are sensitive to pH; some raw materials are sensitive to oxidation, etc. Decomposition products of unstable substances are likely to be the source of foreign matter.
3. Pre-freezing can reduce the difference in size of ice crystals and the inhomogeneity of drying rate caused by differences in nucleation temperature, improve drying efficiency and product uniformity; strengthen crystallization, and increase the crystallization rate of crystalline components and unfrozen water.
LABOAO in-situ freeze dryer is a research and development type freeze dryer. It adopts temperature and high-performance control unit to realize precise and stable control of temperature and vacuum degree. Combined with high-speed cooling ability, the comprehensive performance of the equipment can reach that of similar models. higher level.
LABOAO in-situ freeze dryer can explore the freeze-drying process, explore the eutectic point, help users obtain a better freeze-drying curve, shorten the freeze-drying cycle, and obtain the best product performance and appearance.
[Common problems in the freeze-drying process of antibiotics]
In the production practice of freeze-dried powder injection, we found that the antibiotic bottle is prone to "broken bottle" phenomenon during freeze-drying. While inspecting the quality of antibiotic bottles, we focused on the freeze-drying process and analyzed the causes of "broken bottles".
1. It is related to the freeze-drying curve, pre-freezing too fast, etc. When the sample is frozen, the volume expands rapidly, which will produce a certain expansion force on the bottle body, which usually occurs in the pre-freezing stage, which is the main cause of bottle cracking.
2. If the temperature rises too fast, the thickness of the liquid medicine is relatively thick. After freezing, ice is a poor conductor of heat, and it is easy to cause a large temperature difference between the bottom of the bottle and the body of the bottle. The temperature difference is large, and the stress on each part of the bottle is different. Different, resulting in glass bottles cold burst off the bottom, which is the main reason for the bottom drop.
Solutions and measures:
1. Note that the curve during pre-freezing and sublimation should not be too steep, and the time should be relatively long to reduce the impact on the bottle's thermal expansion and contraction.
2. For the phenomenon of falling ground during pre-freezing, slow freezing can be used to change the crystal form of the drug, so that the frozen product will not fall. This situation has also occurred in our production, and we use this method Solve this problem.
3. The freeze-drying cycle is closely related to the eutectic temperature of the sample, loading capacity, total solid content ratio, drug column height, sublimation rate, sample space structure characteristics and other factors, as well as the determination and adjustment of various freeze-drying parameters.