Sustained-release dry suspension containing a proton pump inhibitor, and preparation method thereof
A proton pump inhibitor and dry suspension technology, which is applied in the directions of medical preparations containing active ingredients, pharmaceutical formulas, medical preparations without active ingredients, etc., can solve the complex preparation process, high risk, long cycle, etc. problem, to achieve the effect of simple process, good safety and easy industrial production
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Embodiment 1
[0051] Preparation of enteric-coated pellets of proton pump inhibitors
[0052] According to the proportioning in Table 1, the prescription amount of pantoprazole sodium, microcrystalline cellulose AVICEL PH101, hypromellose E5 and sodium carbonate were weighed and placed in a high-efficiency wet mixing granulator and stirred for 10 minutes. Slowly add the prescribed amount of purified water into the granulator, and continue to stir for 2 minutes after adding the water to prepare the soft material. The prepared soft material is transferred to a multifunctional pellet coating machine and extruded with a 400 μm extrusion orifice. The extrudate is placed in the rounding pot of the multi-functional pill making and coating machine for rounding. After spheronizing, place it in a hot air circulation oven and dry it to obtain the drug-loaded pellet core 1 .
[0053] The drug-loaded pellet core 1 is coated with an isolation layer and an enteric-coated layer in sequence to obtain pant...
Embodiment 2
[0057] dry suspension preparation
[0058] 1. According to the ratio in Table 2, pass xanthan gum with a particle size of 160 μm, citric acid with a particle size of 120 μm, and crospovidone XL-10 with a particle size of 30 μm through an 80-mesh sieve to remove possible knots. Block or agglomerate, then weigh the prescription amount and sieve the excipients respectively and place them in a mixer for mixing, the mixing time is 5 minutes.
[0059] 2. Weigh the particle size distribution of the prescription amount as D 10 Less than 80μm, D 50 Less than 150μm, D 90 For anhydrous glucose less than 425μm, pass through an 80-mesh sieve and weigh about 1 / 3 of the prescription amount of fine powder, and set aside. The sieved coarse particles and the remaining prescription amount of anhydrous glucose are set aside.
[0060] 3. Add about 1 / 3 of the prescribed amount of anhydrous glucose fine powder passed through a 80-mesh sieve in step 2 to the mixer in step 1 and continue mixing for...
Embodiment 3
[0067] dry suspension preparation
[0068] According to the ratio in Table 3, hypromellose with a particle size of 150 μm, malic acid with a particle size of 100 μm and croscarmellose sodium with a particle size of 75 μm were passed through an 80-mesh sieve to remove possible knots. block or form agglomerates, then weigh the prescription amount and sieve the excipients respectively and place them in a mixer for mixing, and the mixing time is 3 minutes.
[0069] 2. Weigh the particle size distribution of the prescription amount as D 10 Less than 80μm, D 50 Less than 150μm, D 90 For mannitol less than 425 μm, pass through an 80-mesh sieve and weigh about 1 / 3 of the prescription amount of fine powder, and set aside, and use the sieved coarse particles and the remaining prescription amount of mannitol for use.
[0070] 3. Add about 1 / 3 of the prescribed amount of mannitol fine powder passed through the 80 mesh sieve in step 2 to the mixer in step 1 and continue mixing for 10 mi...
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