A crystal modifier for improving the physical properties of chemical drug raw material powder and its preparation method
A technology of modifiers and raw material powders, which is applied in the field of crystal modifiers and their preparations to improve the physical properties of chemical drug raw material powders. shape effect
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Embodiment 1
[0034] Example 1: Hypromellose-paracetamol crystalline modification tablet compression process (API: 87.30%)
[0035] Paracetamol (100 mesh) 10.10kg
[0036] Modifier A-1 2.10kg
[0037] Preparation Process:
[0038] 1. Modifier preparation
[0039] Take 0.10 kg of hypromellose (3-10 mPa·s) and dissolve it in 2.40 kg of water under stirring to obtain modifier A-1.
[0040] 2. Preparation of modifiers
[0041] (1) Take acetaminophen (needle crystal) and pulverize it, pass through a 100-mesh sieve to obtain I.
[0042] (2) Put I in a high-speed mixing granulator, stir at a low speed, slowly add modifier A-1, cut and granulate at a low speed, mix until the cutting current is 4.0A, and obtain II.
[0043] (3) Put II in the fluidized granulator, control the inlet air temperature to 70°C, the humidity to 45% to 65%, and the moisture to 1.5% to 2.5%. The obtained intermediate product was passed through a 30-mesh sieve to obtain 10.15 kg of hypromellose-paracetamol crystalline mod...
Embodiment 2
[0076] Example 2: Hypromellose-sulpiride crystalline modification tablet compression process (API: 77.93%)
[0077] Sulpiride (100 mesh) 10.20kg
[0078] Modifier A-2 2.40kg
[0079] Preparation Process:
[0080] 1. Modifier preparation
[0081] Take 0.05 kg of hypromellose (3-10 mPa·s) and dissolve it in 2.45 kg of alcohol-containing water (weight percentage: ethanol: water = 50:50) under stirring to obtain modifier A-2.
[0082] 2. Preparation of modifiers
[0083] ⑴ Take the raw material of sulpiride, pulverize it, and pass through a 100-mesh sieve to obtain I.
[0084] (2) Put I in a high-speed mixing granulator, stir at a low speed, slowly add modifier A-2, cut and granulate at a low speed, mix until the cutting current is 3.6A, and obtain II.
[0085] (3) Put II in the fluidized granulator, control the inlet air temperature to 70°C, the humidity to 45%-65%, and the moisture content to be 1.0%-2.0%. The obtained intermediate product was passed through a 30-mesh siev...
Embodiment 3
[0095] Example 3: Hypromellose-amlodipine besylate crystal modification tablet compression process (API: 3.93%)
[0096] Amlodipine besylate (100 mesh) 10.10kg
[0097] Modifier A-3 2.20kg
[0098] Preparation Process:
[0099] 1. Modifier preparation
[0100] Take 0.10 kg of hypromellose (3-10 mPa·s) and dissolve it in 2.40 kg of alcohol-containing water (weight percentage: ethanol: water = 30:70) under stirring to obtain modifier A-3.
[0101] 2. Preparation of modifiers
[0102] (1) Take amlodipine besylate raw material and pulverize it, pass through a 100-mesh sieve to obtain I.
[0103] (2) Put Ⅰ in a high-speed mixing granulator, turn on low-speed stirring, slowly add modifier A-3 into the granulator, turn on low-speed cutting and granulating, mix until the cutting current is 3.8A, and get Ⅱ.
[0104] (3) Put II in the fluidized granulator, control the inlet air temperature at 70°C, humidity at 45% to 65%, dry, and control the moisture at 2.0% to 2.5%. The obtained i...
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