Study On Synthsis And Preparation Of Dutasteride

Dutasteride is the second generation 5α- reductase inhibitor which is developed by Glaxo Smith Kline Company. It is the first and the sole medicine which can inhibit type I and type II 5α- reductase. It is used in the clinical treatment of patients with benign prostatic hyperplasia(BPH). It can greatly improve the clinical symptoms of BPH and has the role of prevention of prostate cancer.In this paper, it optimizes the synthetic route of dutasteride with cheap pregnene ketene acid as the initial raw materials. Simple synthetic route, low cost and high total yield make it suitable for industrial mass production.The quality standard of Dutasteride was established, and the high performance liquid chromatography method was established for the determination of the content.The method is accurate, sensitive and convenient. The three batches of samples are in line with the standard after the content inspection.During the preparation of dutasteride soft capsule, we screened the prescription of soft capsule shell. After respectively inspecting the plasticizer, disintegrating agent,colorant, sunscreen and other factors, the optimal formulation was selected.Through the determination of the dissolution curve in four different dissolution medium and the comparison of formulation relevant characteristics between self-made samples and original development medicines, we can draw a conclusion that self-made samples are similar to original development medicines. We can make a preliminary estimate that the two drugs have bioequivalence.The high performance liquid chromatography method was established for the determination of the content and the dissolution of the test. The method is accurate,sensitive and convenient. The three batches of samples are in line with the standard after the content and the dissolution inspection.