Application of Quality by Design in the Development of Hawthorn Malt Micro Effervescent Tablet
Based on the concept of quality by design and the understanding of the dosage form characteristics and process of the developed product,the formulation of hawthorn malt micro effervescent tablets was designed and optimized with hawthorn and malt as the main raw materials of Chinese medicinal herbs of the same origin as food and medicine.By analyzing the material properties and determining the key quality attributes(CQAs)affecting the micro effervescent tablets,such as taste,hardness,disintegration time limit and content,the formulation and process parameters of the micro effervescent tablets were optimized,and the process parameters of hawthorn malt micro effervescent tablets were preferred as the dosage of 15％of sodium bicarbonate as the alkali disintegrant,17.5％of citric acid anhydrous as the acid disintegrant,and 1.7％of magnesium stearate in the prescription.When this formulation parameter was used,preliminary quality evaluation of hawthorn malt micro effervescent tablets was carried out to obtain samples experiencing a good taste with the characteristic flavor of the product,stable process and qualified quality.
extract from hawthorn maltmicro effervescent tabletapplication of quality by designformula design
NETL
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万方数据
维普
