Amlodipine besylate tablet for treating hypertension and preparation method thereof
A technology of amlodipine besylate tablets and amlodipine besylate, which is applied to chemical instruments and methods, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve problems such as dissolution instability, and achieve simple structure , simple preparation process and convenient operation
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Embodiment 1
[0017] Weigh 15g of amlodipine besylate, 35g of microcrystalline cellulose, 50g of lactose, 15g of L-tyrosine, 35g of pregelatinized starch, 20g of calcium sulfate dihydrate, 8g of croscarmellose sodium, and 8g of crosslinked Povidone 8g, magnesium stearate 1g.
[0018] Preparation process: put the amlodipine besylate raw material in a pulverizing equipment to pulverize; mix the pulverized amlodipine besylate raw material with the above-mentioned excipients in a particle mixer according to the amount, granulate according to a conventional method, press Tablets, packed into finished products.
[0019] Particle mixers above, see figure 1 , comprising a stirring barrel 1, a stirring shaft 2 arranged in the stirring barrel 1 and a stirring motor 3 arranged on the stirring barrel 1 and connected with the stirring shaft 2, and the stirring shaft 2 is provided with a stirring The paddle 4 is provided with a through hole 5 on the stirring paddle 4, an annular groove 6 is provided on...
Embodiment 5
[0032] The release research of embodiment 5 amlodipine besylate tablets
[0033] Get respectively the tablet that the embodiment of the present invention 1, comparative example 2-4 prepare, according to dissolution assay (" Chinese Pharmacopoeia > 2010 edition two appendix X c second method), take hydrochloric acid solution (0.9→1000mL) as Solvent, the rotating speed is 75 revolutions per minute, operate according to the law, after 15 minutes, take an appropriate amount of solution, filter, and take the subsequent filtrate as the test solution; in addition, accurately weigh amlodipine besylate dried to constant weight at 105 °C An appropriate amount of standard substance was added to hydrochloric acid solution to make a solution containing 10g amlodipine besylate per 1ml, as a reference substance solution. Precisely measure the appropriate amount of the above two solutions, according to spectrophotometry ("Chinese Pharmacopoeia > 2010 edition two appendix VIA), respectively me...
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