Pharmaceutical combination containing glucokinase activator and PPAR receptor activator and its preparation method and use
A technology of glucokinase and receptor activator, which is applied in the field of oral solid preparations to treat and/or prevent one or more diseases and medical conditions. And other issues
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[0316] Scheme 29. The method for preparing the pharmaceutical combination, pharmaceutical composition or fixed dose combination preparation according to scheme 28, wherein it is prepared by wet granulation (high shear and / or fluidized bed), or by dry processing (direct compression or dry process) pellets) preparation.
[0317] Item 30. The method for preparing the pharmaceutical combination, pharmaceutical composition or fixed dose combination according to any one of items 28-29, wherein the glucokinase activator is prepared in the form of a solid dispersion.
[0318] Scheme 31. The method for preparing a pharmaceutical combination, a pharmaceutical composition or a fixed-dose compound preparation according to any one of schemes 28-30, wherein the glucokinase activator and the second or more active ingredients can also be prepared together into a compound Solid dispersion form (ie a solid dispersion containing 2 or more active ingredients).
[0319] Scheme 32. The pharmaceuti...
Embodiment approach II
[0322] Embodiment II - glucokinase activator + PPAR receptor activator - (eg pioglitazone)
[0323] Scheme 1. A pharmaceutical combination, pharmaceutical composition or fixed-dose compound preparation comprising:
[0324] (a) A glucokinase activator, which is a compound represented by the following formula, or a pharmaceutically acceptable salt thereof, an isotope label, a crystal form, a hydrate, a solvate, a diastereoisomer or an enantiomer form,
[0325]
[0326] (b) PPAR receptor activators;
[0327] (c) one or more excipients;
[0328] Wherein the above drugs (a) and (b) are used simultaneously, separately or sequentially.
[0329] Scheme 2. The pharmaceutical combination, pharmaceutical composition or fixed dose compound preparation of Scheme 1, wherein the weight ratio of the glucokinase activator to the PPAR receptor activator is about 50:1 to 1:10, preferably about 25 :1 to 1:5, more preferably about 1:10, about 1:5, about 1:2, about 1.67:1, about 3.33:1, abou...
Embodiment
[0424] Preparation of compound tablet of glucokinase activator
[0425] The chemicals used in the present invention can be purchased from companies such as Shin-Etsu Japan, Evonik Germany, J.T. Baker US, SCR China, Ashland US, FMC US, JRS Germany, Colorcon US, Capsugel, BASF, revitalizing reagents, etc. Production equipment and analytical testing instruments etc. can be purchased from such companies as Sartorius, Nikon, Sympatec, Bruker, Gea Niro, Korsch, Erweka, Agilent, Quadro Engineering, Canada; Warters, US; TA, US; SOTAX, Switzerland; Mettler Toledo Instrument Newark, DE.
[0426] I. Preparation of Solid Dispersion of Glucokinase Activator
[0427] 1.1 Preparation of solid dispersion solution before spray drying
[0428] Example 1A (the weight ratio of active ingredient to polymer is 1:9)
[0429] Weigh 6.75 grams of Eudragit L100 (Evonik L100, Evonik Germany), add it to absolute ethanol (J.T.Baker) under stirring conditions, add 0.75 grams of compound HMS5552 after it...
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