Procedure for the manufacture of a Pharmaceutical composition in the form of extended release Tablets containing Pirfenidone and its application in regression of renal insufficiency cronicA, Breast capsular contracture and Human hepatic fibrosis

摘要

1. Procedures for the manufacture of long-term release of pharmaceutical ingredients in the form of tablets, from 600 mg to 2400 mg of pidan (PFD),Therefore, the drug containing the substance can be bioavailable within 12 hours after use, so as to optimize the anti fibrotic and anti-inflammatory effects of the drug. In addition, in the process of reducing second-order chronic renal failure to first-order glomeroesclerosis, it provides advantages and efficiency in oral and therapeutic aspects for other forms of pidan drugs;It is better in the reduction and / or reduction of breast cancer damage observed after breast implantation, and has taken significant anti TNF-a and anti tf-b1 actions in the treatment of liver fibrosis. 1. To produce a pharmaceutical component in the form of a long-term release tablet, including 600 mg of pyridan;The procedure includes the following steps: (1) sieving pidan and silica on the oscillating particles with No. 30 mesh, putting them into a list mixer, mixing for 5 minutes; (2) microcrystalline cellulose. Hydroxypropylmethylcellulose (HPMC) with low viscosity and hydroxypropylmethylcellulose (HPMC) with high viscosity were screened on the oscillator particles for 30 times by mesh screening, and placed on the list agitator in step 1 for mixing for 15 minutes; step 3) screened on the oscillator particles for 30 times by mesh screening, and then placed on the oscillator. 1. In the skateboard mixer in step 1, mix for 3 minutes;Step (4) extract the particles with a circular Stokes plate. The compression parameters are as follows: average weight: 850 Mg + 5%;Hardness: up to 10 kg f; coolability: less than 1%. Requirement 2: a drug composition in the form of long release tablets, including 600 mg of pyridan, is obtained according to the procedure of requirement 1, wherein the long release tablets include the quantity formula:@@@@@@@@@@@@