乳核内消液减少沉淀的方法试验

Reduction precipitates method research of Ruhe Neixiaoye

目的优选工艺提高乳核内消液产品稳定性,减少不溶物析出。方法采用高速离心、升温保压、再高速离心的方法处理初药液,将产品的沉淀降至最低。结果及结论用此方法生产三批产品,通过一年的留样考察,产品稳定,合格率高。临床试验证明功效没有改变。

OBJECTIVE Chooses the best craft to enhances stability of Ruhe Neixiaoye. METHODS Three steps were used which included high speed centrifugation, calefaction and keeping pressure and high speed centrifugation to treat Ruhe Neixiaoye . It was proved the method could reduce precipitates in products. RESULTS and CONCLUSION Using the method to produce three group outputs and reviewing sample for one year, The results showed that the product stability and qualified rate were improved,and the clinical test proof effect had not changed.