Study On The Formulation,Process And Quality Standard Of Dutasteride Soft Capsule

Benign prostatic hyperplasia(BPH)is a common disease of the older men.With the increase of age,the disease becomes increasingly serious and a series of complications appear,which seriously affect the quality of life of patients.Dutasteride is a new 5-α-reductase inhibitor that is inhibited the 5-α reductase I and II.Compared with other 5-α reductase inhibitors,it works faster and more effectively.The product was de veloped by Glaxosmithkline and launched in the United States in 2001.C hina approved the import of the drug in 2011,but so far,no generic drug has approved in china.In this paper,dutasteride soft capsule was developed by Glaxosmithkline was used as the reference listed drug,in order to develop dutasteride soft capsule with the same quality as the reference listed drug,so as to provide better and cheaper treatment medicine for the majority of patients.The research work of this paper includes the following three aspects:(1)Study on the formulation and preparation process of dutasteride soft capsule:Based on the formulation of reference listed drug,the effect of glycine on delaying cross-linking was investigated.The formulation and preparation process of the product were determined by studying the preparation temperature and temperature condition of the contents,the dispersion method and adding order of the shading agent and colouring agent,and the control standardof the loss on drying of the capsule.The research results show that the formulation is reasonable,the preparation process is stable and the repeated reproducibility is good.(2)Research the analytical method and establishment of quality standard for Dutasteride soft capsule:According to the imported registration standard of Dutasteride soft capsule,the analysis method was optimized and the suitable analysis method was deve loped.Combined with the actual quality of self-developed products,the quality standards and limits are established.(3)Study on the quality and stability of Dutasteride soft capsule:The quality and stability of the self-developed product and the reference listed drug were comparative studied.Four dissolution curves in four kinds of dissolution media and the growth of related substances in the process of stability study were compared.The research results showed that the dissolution behavior of the self-developed product was similar to that of the reference listed drug.Dutasteride soft capsules(0.5 mg)were successfully prepared by the above three aspects of research.The product has the same quality and good stability as the reference listed drug.At the same time,the method in the import registration standard was optimized.The new method can better reflect and control the quality of dutasteride soft capsule.