Optimization of the conditions for the synthetic preparation of iron sucrose complex by response surface methodology / 国际药学研究杂志

ABSTRACT

Objective To optimize the conditions for the synthetic process of iron sucrose complex (ISC), via the investigation of the effects of reaction temperature (X1), reaction time (X2), amount of alkali (X3), and amount of sucrose (X4) on the relative molecular mass of the ISC product. Methods According to the experimental results for the single factor, the conditions dealing with the X1, X2, X3, and X4 parameters for the preparation of ISC were optimized by the Box-Behnker design combined with the response surface methodology using the weight average relative molecular mass of ISC as an indicator, and analyzed with gel permeation chromatography. Results The reaction temperature and the amount of alkali had a significant effect on the weight average relative molecular mass of ISC. The influence of the four factors in the descending order was as follows:X3＞X1＞X2＞X4. In the designed experimental conditions, theresponsevaluedecreasedwiththeincreaseofbothreactiontemperaturesandalkaliamounts. Conclusion Theresponse surface methodology could provide the relationship between the response values and variables via the minimum number experiments to obtain the optimized conditions for the preparation of ISCs.