维生素D2果糖酸钙注射液稳定性的研究

维生素D₂果糖酸钙注射液为非均匀体系的乳浊液。维生素D₂在油溶液中很稳定,而在此注射液中不稳定,其主要原因在于为非均匀体系乳浊所致,以界面对稳定性的影响最大。乳化剂用量增加维生素D₂稳定性亦降低。根据此注射液不稳定的主要原因,采用了添加油溶性抗氧剂和充以惰性气体的抗氧化措施,结合乳浊液的特点,此种措施是合理的,留样观察证明也是有效的。

STUDIES OF THE STABILITY OF CALCIFEROL AND CALCIUM LEVULINATE INJECTION

In order to improve the stability of calciferol in an emulsion type injection, calciferol and calciun levulinate injection, the effects of oil medium, aqueous phase, interfacial area, calcium ions and concentrations of emulsifiers on the stability of calciferol were investigated.Calciferol was highly stable in oil medium, but tended to be oxidized in the presence of aqueous phase or calcium ions, and in the increase of interfacial area. Among these factors, the interfacial area was found to be most important in affecting the stability of calciferol.The extent of oxidation of calciferol increased with increasing concentrations of the emulsifiers used.The incorporation of butyl hydroxy ahisol and filling the ampule space with nitrogen gas were effective in improving the stability of calciferol in the emulsion type injection.