Novel Paricalcitol soft capsule and preparation method thereof

Abstract

The invention discloses a novel Paricalcitol soft capsule and a preparation method thereof, and particularly relates to the technical field of pharmaceutical preparations. The soft capsule comprises asoft capsule filling liquid and a soft capsule shell, and the filling liquid is composed of Paricalcitol, refined vegetable oil, a buffer agent and a flavoring agent; and the capsule shell consists of gelatin, a thickening agent, a flavoring agent, water and an opacifying agent. The Paricalcitol soft capsule filling liquid prepared by the method disclosed by the invention is stable in quality. The soft capsule can be chewed and taken, the capsule shell does not absorb water to be softened, the soft capsule is used for treating secondary hyperparathyroidism and the like of patients suffering from chronic renal failure after hemodialysis, the disintegration time is shortest, the effect taking speed is high, and the bioavailability is high, so that the Paricalcitol soft capsule is obviouslysuperior to existing products.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, more specifically, the invention relates to a novel paricalcitol soft capsule for treating osteoporosis and a preparation method thereof. Background technique [0002] Paricalcitol is a synthetic bioactive vitamin D analog with the molecular formula C 27 h 44 o 3 , is a vitamin D analog developed by Abbott. Like calcitriol, it exerts corresponding physiological effects by binding to vitamin D receptor (VDR). It is used for the treatment of chronic renal failure patients undergoing hemodialysis. Sexual hyperparathyroidism (SHPT). It can inhibit parathyroid hormone faster and longer, and has little effect on calcium, phosphorus and calcium-phosphorus deposition, so persistent hypercalcemia is less likely to occur, and the drug’s efficacy in reducing aortic calcification and improving bone quality is also It is better than calcitriol, and can reduce the mortality rate, hospit...

AI Technical Summary

Problems solved by technology

At present, there are only two dosage forms of paricalcitol in the market: soft capsule and injection, the dosage form is relatively single, and patients have less choice

Moreover, the administration of injections is inconvenient and the use is limited; soft capsules generally have poor stability, and long-term storage is easy to absorb moisture, which affects disintegration and content, thereby affecting bioavailability and curative effect

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