Diltiazem hydrochloride control release capsule and its preparing method
A technology of diltiazem acid and capsules, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and drug delivery, etc. problem, to achieve the effect of controlling blood drug concentration
Examples
Embodiment 1
[0083] Operation step a, preparation of drug-containing pellets 3
[0084] 1. Weigh 500g of commercially available pellets 1 with 30-36 mesh specifications, put them into the bottom spray fluidized bed coating machine, start the machine and adjust the air intake to make the pellets in a proper fluidized state;
[0085] 2. Spray the suspension made of 1100g diltiazem hydrochloride, 100g hydroxypropyl methylcellulose (HPMC 6mPaS), 3000g 50% ethanol into the surface of the pellet 1 at a speed of 5-15ml / min to form Drug storage layer 2, this process controls the inlet air temperature to 40-60°C, and the atomization pressure to 1.5×10 5 Pa;
[0086] 3. Continue to pass hot air to dry and discharge;
[0087] 4. Sieve to obtain 1632g of medicated pellets.
[0088] b, package controlled release film layer 4
[0089] 1. Feed 700g of the above drug-containing pellets into the bottom spray fluidized bed coating machine, and inject hot air to make it into a proper fluidized state;
...
Embodiment 2
[0100] a. Preparation of drug-containing pellets 3
[0101] 1. Weigh 500g of commercially available pellets 1 with 30-36 mesh specifications, put them into the side-spray fluidized bed, start the machine and adjust the air intake to make the pellets in a proper rotation state;
[0102] 2. Spray the solution made of 100gHPMC and 2500g water at a speed of 5-15ml / min, and sprinkle the mixed powder consisting of 1800g diltiazem hydrochloride powder at the same time to form the drug storage layer 2. This process controls the inlet air temperature to 40 ~60℃, atomization pressure 1.6×10 5 Pa;
[0103] 3. Continue to pass in hot air to dry and discharge;
[0104] 4. Sieve to get 2304g of pellets.
[0105] b, package controlled release film layer 4
[0106] 1230g of the above-mentioned drug-containing pellets are coated according to the following prescription liquid:
[0107] Ethyl cellulose aqueous dispersion (containing 30% solids) 607g, methyl methacrylate: ethyl acrylate: tri...
Embodiment 3
[0115] a. Preparation of drug-containing pellets 3
[0116] 1. Mix 1400g of diltiazem hydrochloride powder, 900g of microcrystalline cellulose, 100g of sucrose powder, and 100g of starch in a stirring granulator, add about 2100g of 3% HPMC aqueous solution and mix to make a soft material;
[0117] 2. The soft material is extruded and rounded into pellets in the extrusion-rounder; the screen aperture of the extruder is 0.8mm, the extrusion speed is 30-70rpm, the speed of the rounder is 600-1100rpm, and the rounding time is 3-9 minutes ;
[0118] 3 The pellets are dried at a temperature of 45-65°C;
[0119] 4. Sieve to obtain 2489g of medicated pellets.
[0120] b, package controlled release film layer 4
[0121] Take by weighing 1000g of the above-mentioned drug-containing pellets and carry out coating according to the following prescription liquid:
[0122] Ethyl cellulose (pharmaceutical grade, 12mPaS) 45.5g, methacrylic acid:methyl methacrylate 1:1 polymer 0.2g, methacry...
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Abstract
Description
Claims
Application Information
- IPC
- A61K9/52; A61K31/554; A61P9/10; A61P9/12
- Inventors
- 张霖泽; 梁超峰